Slide 1
Slide 1 of 90
FACULTY ANNOUNCEMENTS
[Note: Please follow
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes FACULTY ANNOUNCEMENTS
[Note: Please follow ARHP guidelines for CME presentations by including all required information in your introduction. This information is in your teaching packet. As a faculty representative, you are requested to do the following:]
- Announce program sponsor: Association of Reproductive Health Professionals (ARHP).
- Announce unrestricted educational grant from Wyeth.
- Announce that the presentation may include information that is not on FDA-required product labels.
- Disclose any financial relationship with the grantor, or any companies whose products are mentioned in this presentation, including type of relationship.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 2
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Talking Points:
This presentation has been
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points:
This presentation has been peer reviewed. You have more details about each of these medical experts in your handout.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 3
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Talking Points:
This presentation has been
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points:
This presentation has been peer reviewed. You have more details about each of these medical experts in your handout.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 4
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Talking Points
This presentation:
Reviews
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This presentation:
- Reviews studies on attitudes and practices of health care providers and women about extended use of contraception and menstrual suppression
- Presents research on extended use of various contraceptive methods
- Outlines specific approaches to counseling
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 5
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Talking Points
Is monthly menstruation
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Is monthly menstruation really a natural state?
- Preagricultural women had about 160 lifetime menstrual cycles. That number has almost tripled to about 450 cycles for contemporary women who live in industrial, Western nations.
Source
- Eaton SB, Pike MC, Short RV, et al. Women’s reproductive cancers in evolutionary context. Q Rev Biol. 1994;69:353-367.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 6
Slide 6 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The higher number of menstrual cycles in modern women is attributed to earlier menarche, lower parity, shorter periods of breastfeeding, and later menopause.
Source
- Eaton SB, Pike MC, Short RV, et al. Women’s reproductive cancers in evolutionary context. Q Rev Biol. 1994;69:353-367.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 7
Slide 7 of 90
Talking Points
Menstrual disorders are the
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Menstrual disorders are the leading cause of gynecological morbidity, affecting 2.5 million women annually.
- Of the 2.5 million women in the US who suffer from menstrual disorders, about 65 percent contact their clinician for menstrual symptoms.
- Of 2.5 million women aged 18–50 years who have menstrual disorders, 31 percent report spending a mean of 9.6 days in bed each year, resulting in costs to American industry of an estimated 8 percent of the total wage bill.
- Based on data from a 1999 survey of US women, investigators estimated that women with heavy menstrual flow worked 6.9 percent less, or 3.6 fewer weeks yearly, with estimated lost wages of about $1,692 per woman annually.
Sources
- Kjerulff KH, Erickson BA, Langenberg PW. Chronic gynecological conditions reported by US women: findings from the National Health Interview Survey, 1984 to 1992. Am J Public Health. 1996;86:195-199.
- Dalton K, Holton W. Once a Month: Understanding and Treating PMS, 6th ed. Alameda, Ca: Hunter House; 1990.
- Cote I, Jacobs P, Cummings D. Work loss associated with increased menstrual loss in the United States. Obstet Gynecol. 2002;100:683-687.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 8
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Talking Points
Regulating menstruation can
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
Regulating menstruation can help improve these menstrual-related gynecologic disorders.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 9
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Talking Points
Regulating menstruation can
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
Regulating menstruation can lead to a reduction in these menstrual-related medical disorders.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 10
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Talking Points
A randomized clinical trial
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- A randomized clinical trial involving 36 women aged 18–35 found that continuous OC regimens more effectively prevent dominant follicle development and breakthrough ovulation with low-dose OCs.
- The slight delay in time to ovulation following OC discontinuation and natural cycles could be attributed to suppression of follicle wave activity.
- Extended/continuous use has the potential to increase the efficacy of low-dose combined hormonal methods by preventing increased follicular activity/escape ovulation during the pill-free week, particularly among poor pill takers
Source
- Birtch RL, Olatunbosun OA, Pierson RA. Ovarian follicular dynamics during conventional vs. continuous oral contraceptive use. Contraception. 2006;73:235-243.
---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for
Choosing When to Menstruate: The Role of Extended Contraception in April 2003. Original funding received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for
Choosing When to Menstruate: The Role of Extended Contraception in May 2006. This slide is available at www.arhp.org/core.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 11
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Talking Points
Red line= theorized pattern
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Red line= theorized pattern during OCP cycle with 7 day HFI
- Purple line= typical pattern during spontaneous menstrual cycle
- With a hormone-free interval (HFI) of 7 days, FSH begins to increase on cycle day 3 to 4, allowing follicular recruitment and estradiol production. When active pills are reinitiated, follicles degenerate and estrogen withdrawal begins before the next HFI.
Source
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 12
Slide 12 of 90

Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This interventional, observational study compared ovulation inhibition and ovarian activity with two different regimens using an OC with 15 mcg of ethinyl estradiol (EE) and 60 mcg of gestodene in 58 women age 18–35 years.
- Ovarian activity was monitored every other day with ultrasound to measure the diameters of the follicle-like structures. Blood samples were obtained to measure serum concentrations of 17 beta-E2 and progesterone.
- This slide shows the mean diameter of the largest follicle-like structures seen with both regimens.
- FSH rose in both groups during HFI but better suppression was observed in the 24/4 group.
Source
- Sullivan H, Furniss H, Spona J, et al. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microgr) and ethinyl estradiol (15 microg) on ovarian activity. Fertil Steril. 1999;72:115-120.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 13
Slide 13 of 90
Talking Points
The estradiol level was less
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The estradiol level was less than 50 pg/ml throughout the 24/4 cycles, but increased to greater than 100 pg/ml in the 21/7 cycles.
- Post-treatment cycle ovulation: all subjects in the 24/4 group but only 18 of 24 in the 21/7 group ovulated after treatment ended (six had luteinized unruptured follicles).
- Breakthrough bleeding (BTB) appeared to be higher in the 24/4 group.
Source
- Sullivan H, Furniss H, Spona J, et al. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microgr) and ethinyl estradiol (15 microg) on ovarian activity. Fertil Steril. 1999;72:115-120.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 14
Slide 14 of 90

Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This double-blind, randomized, multicenter trial of 60 women sought to determine the suppressive effect on ovarian activity of 20 mcg EE plus 75 mcg gestodene administered for either 21 or 23 days.
- Five cycles: One pretreatment, three treatment, one post-treatment with monitoring by ovarian ultrasound, LH, FSH, 17 beta-E2, and progesterone measurements every other day.
- No ovulation and no luteinized, unruptured follicles were observed.
- Suppression of ovarian activity (follicular development and estradiol levels) was superior with the 23/5 regimen, suggesting that shortening the pill-free interval may increase the contraceptive safety margin in women on low-dose OCs.
Source
- Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996;54:71-77.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 15
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Talking Points
Researchers have tested
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Researchers have tested various approaches to the hormone- free interval (HFI)
- A randomized, double-blind study in which women received Mircette® (20 mcg EE plus 150 desogestrel) for 21 days and either a placebo for 7 days or placebo for 2 days and 10 mcg of EE for 5 days.
- During cycles 2 and 3, the Mircette®/placebo group had a higher incidence of persistent ovarian follicles and on average a greater maximum follicle diameter than the Mircette®/EE group.
- One Mircette®/placebo subject probably ovulated in cycle 2, and another had a luteinized unruptured follicle. No such activity was seen in the Mircette®/EE group.
Source
- Killick SR, Fitzgerald C, Davis A. Ovarian activity in women taking an oral contraceptive containing 20 microg ethinyl estradiol and 150 microg desogestrel: effects of low estrogen doses during the hormone-free interval. Am J Obstet Gynecol. 1998;179:S18-S24.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 16
Slide 16 of 90
Talking Points
This randomized controlled
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This randomized controlled clinical trial evaluated ovarian follicular development in women during compliant use of three different OCs for three consecutive 28-day OC cycles.
- Seventeen of 36 women (47%) grew follicles >14 mm in association with increased serum concentrations of 17 beta E2.
- Thirty-seven of 43 follicles >10 mm (86%) emerged during the hormone-free interval.
- No ovulations occurred.
Source
- Baerwald AR, Olatunbosun OA, Pierson RA. Ovarian follicular development is initiated during the hormone-free interval of oral contraceptive use. Contraception. 2004;70:371-377.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 17
Slide 17 of 90
Talking Points
Case-control study of OC
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Case-control study of OC effect on functional ovarian cysts: 392 cases/623 controls
- The overall odds ratio for functional ovarian cyst development was 0.72 for current OC users compared with use of nonsurgical, nonhormonal contraception or no contraception.
- The risk associated with use of a 35 mcg EE monophasic OC was slightly lower (odds ratio [OR] 0.69) than that associated with a monophasic OC with <35 mcg EE (OR 0.79) or multiphasic OCs (OR 0.76).
- Women with tubal sterilization had a substantially increased risk of functional ovarian cyst diagnosis (OR 1.70) compared with women using nonhormonal or no contraception.
- Conclusion: Low-dose OCs have little or no effect on functional ovarian cyst formation.
- However, a 7-day HFI with today’s low-dose OCs allows for follicular development and cyst formation in some patients
Source
- Holt VL, Cushing-Haugen KL, Daling JR. Oral contraceptives, tubal sterilization, and functional ovarian cyst risk. Obstet Gynecol. 2003;102:252-258.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 18
Slide 18 of 90
Talking Points
New and forthcoming pill
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- New and forthcoming pill approvals are focusing on shortening the hormone-free interval.
- Yaz® is a 24-day OC product with four days of placebo pills.
- Loestrin® 24 Fe is a 24-day OC product with four days of placebo pills that contain iron.
- Seasonique® is an 84-day OC product with 7 days of EE 10 mcg.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 19
Slide 19 of 90
Talking Points
A follow-up study was
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- A follow-up study was conducted in France to determine the frequency with which women miss oral contraceptives and to observe their behavior when they forget to take a pill. Women in the study were changed from a continuous-cycle regimen to an interrupted-cycle regimen and vice versa.
- A total of 617 gynecologists enrolled 3,316 women.
- A large noncompliance rate was seen.
- Administration of the pill in a continuous-cycle regimen, as well as study and self-questionnaire effects, contributed to an improvement in compliance.
- In the group taking the continuous-cycle pill, the omission number was slightly decreased, particularly on the first day and week of the cycle.
- The first week of a new pill is an extremely dangerous period because ovulation may not be inhibited if the pill-free interval between two blister packs exceeds either 7 days for pills with 20 and 30 mcg of ethinyl estradiol or 4 days for 15-mcg pills.
Source
- Aubeny E, Buhler M, Colau JC, et al. The Coraliance study: non-compliant behavior. Results from a 6-month follow-up of patients on oral contraceptives. Eur J Reprod Health Care. 2004;9:267-277.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 20
Slide 20 of 90
Talking Points
The benefit rate in terms of
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The benefit rate in terms of omissions (forgetful patients remembering to take their pill) was 1.7% in the interrupted-cycle pill group and 8.5% in the continuous-cycle pill group (P<0.0001).
- This study suggests a trend toward improved success with continuous use; it is likely to improve pill-taking by eliminating risk of forgetting to take pill after discontinuation during traditional week between 2 blister packs.
- More studies are needed to confirm this finding.
Source
- Aubeny E, Buhler M, Colau JC, et al. The Coraliance study: non-compliant behavior. Results from a 6-month follow-up of patients on oral contraceptives. Eur J Reprod Health Care. 2004;9:267-277.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 21
Slide 21 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 22
Slide 22 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 23
Slide 23 of 90
Talking Points
ARHP commissioned a survey
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- ARHP commissioned a survey in summer 2005 to determine women’s views of their menstrual cycles.
- The Internet survey of more than 1,000 women aged 18–40 revealed that women harbor many misconceptions about and an incomplete understanding of menstruation. In particular, safety is a big question for them when it comes to taking hormones and suppressing their periods.
Source
- Association of Reproductive Health Professionals Greenberg Quinlan Rosner Survey, July 8-13, 2005.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 24
Slide 24 of 90
Talking Points
The ARHP Internet survey
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The ARHP Internet survey revealed that women have a love/hate relationship with their period. Many view it as a nuisance. Others view it as a way to keep in touch with their bodies and an indicator of the natural cycles of life.
- Most women do not feel they have to hide the fact that they get their period or feel embarrassed about purchasing tampons or sanitary pads. They just see it as an inconvenience.
- A strong majority of women feel that their period puts them at a disadvantage in today’s society and men have an advantage because they do not get a period.
- Of those who responded, this slide shows whether they agree or disagree with the statement.
Source
- Association of Reproductive Health Professionals Greenberg Quinlan Rosner Survey, July 8-13, 2005.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 25
Slide 25 of 90
Talking Points
Women regularly experience
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Women regularly experience the physical and emotional symptoms of the menstrual cycle in the week before or during their periods. Many women report experiencing severe symptoms during their menstrual periods. Sixty-four percent of the respondents often or sometimes experience heavy bleeding, and 63% have “really bad cramps.”
Source
- Association of Reproductive Health Professionals Greenberg Quinlan Rosner Survey, July 8-13, 2005.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 26
Slide 26 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 27
Slide 27 of 90
Talking Points
When asked how often they
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- When asked how often they would choose to have a period, almost half of women said never, while almost a quarter said they would continue with monthly cycles.
- Many women expressed interest in stopping or delaying their periods: 24% were very interested, 31% were somewhat interested, 22% were not very interested, and 23% were not interested at all.
Source
- Association of Reproductive Health Professionals Greenberg Quinlan Rosner Survey, July 8-13, 2005.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 28
Slide 28 of 90
Talking Points
An ARHP survey conducted in
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- An ARHP survey conducted in 2003 of women aged 18–40 at six sites across the United States, as well as providers, found that many women don’t know about menstrual suppression but would be interested in a safe method that would allow them to stop having periods. Linda Andrist, associate professor at MGH Institute of Health Professions, led the survey.
- Participants felt that more research should be conducted on menstrual suppression and said that factors such as long-term health effects, side effects, future fertility, and cost would influence their decision about whether to use extended-regimen contraception.
- The majority of the women said they would use hormonal contraception to reduce menstrual frequency if they believed the practice was safe.
Source
- Andrist LC, Arias RD, Nucatola D, et al. Women’s and providers’ attitudes toward menstrual suppression with extended use of oral contraceptives. Contraception. 2004;70:359-363.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 29
Slide 29 of 90
Talking Points
In the 2003 ARHP survey, 512
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- In the 2003 ARHP survey, 512 providers at six sites across the United States were surveyed, as well as women.
- Clinicians said they prescribe extended use of oral contraceptives for dysmenorrhea, menorrhagia, and endometriosis, as well as by patient request.
- Providers, like the women surveyed, said that more research should be conducted on extended use, particularly in regard to long-term health effects, side effects, future fertility, and the cost of the regimens.
Source
- Andrist LC, Arias RD, Nucatola D, et al. Women’s and providers’ attitudes toward menstrual suppression with extended use of oral contraceptives. Contraception. 2004;70:359-363.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 30
Slide 30 of 90
Talking Points
A survey of 551 health care
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- A survey of 551 health care providers—primary care physicians, obstetrician/gynecologists, nurse practitioners, and physician assistants—at medical meetings was conducted in 2004 by Patsy Sulak, MD, and colleagues to determine attitudes and prescribing preferences of providers regarding extended-cycle oral contraceptives.
- Most respondents were advocates of extended use and had prescribed it in their practices, reflecting the acceptance of novel contraceptive prescribing regimens in the United States.
Source
- Sulak PJ, Buckley T, Kuehl TJ. Attitudes and prescribing preferences of health care professionals in the United States regarding use of extended-cycle oral contraceptives. Contraception. 2006;73:41-45.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 31
Slide 31 of 90

Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Physicians and nurse/practitioners who listed their specialty as “ob/gyn” were more likely to favor the concept of routinely offering the option of extended regimens and to recommended extended regimens in their practices.
Source
- Sulak PJ, Buckley T, Kuehl TJ. Attitudes and prescribing preferences of health care professionals in the United States regarding use of extended-cycle oral contraceptives. Contraception. 2006;73:41-45.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 32
Slide 32 of 90
Talking Points
The most commonly recommended
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The most commonly recommended extended regimen was an 84-day active pill use period followed by a 7-day hormone-free interval.
Source
- Sulak PJ, Buckley T, Kuehl TJ. Attitudes and prescribing preferences of health care professionals in the United States regarding use of extended-cycle oral contraceptives. Contraception. 2006;73:41-45.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 33
Slide 33 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 34
Slide 34 of 90
Talking Points
Medical options for reducing
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Medical options for reducing menstruation include:
Injectable progestin-only contraceptives (DMPA)
Progestin-releasing intrauterine device (Mirena®)
Oral progestins (norethindrone acetate, Aygestin®)
Danazol (Danocrine®)
Gonadotropin-releasing hormone analogues (e.g., Leuprolide Acetate, Lupron Depot®)
Extended-use OCs and combination hormonal contraceptives
- Some of these options cyclically reduce frequency of bleeding, such as extended OC regimens. Others are continuous and reduce or eliminate bleeding.
Source
- Kaunitz AM. Menstruation: choosing whether…and when. Contraception. 2000;62:277-284.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 35
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Talking Points
150 mg administered IM every
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- 150 mg administered IM every 3 months OR
- 104 mg administered subQ every 3 months
- Highly effective contraception
- Amenorrhea common with long-term use
- Noncontraceptive benefits include treatment of:
- Menorrhagia
- Dysmenorrhea
- Endometriosis
- Side effects: Irregular bleeding or spotting, possible weight gain, delayed return to fertility
- Between 50 and 70 % of women who use DMPA for one year experience amenorrhea.
- A subcutaneous formulation became available in the United States in 2005. It is more efficacious than the original Depo-Provera, but with 30% less hormone.
- Labeling states this method should be used long-term (e.g., longer than 2 years) only if other methods of birth control are inadequate.
Sources
- Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005;192:998-1004.
- Westhoff C. Depot-medroxyprogesterone acetate injection (Depo-Provera): a highly effective contraception option with proven long-term safety. Contraception. 2003;68:75-87.
- Prescribing information available at: http://www.pfizer.com/pfizer/download/uspi_depo_provera_contraceptive.pdf and http://www.depo-subqprovera104.com/pdf/deposubqPI.pdf
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 36
Slide 36 of 90
Talking Points
Releases 20 µg levonorgestrel
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Releases 20 µg levonorgestrel each day
- Indicated for contraception
- 80%–90% reduction in menstrual blood loss (not associated with copper-T IUD)
- Also effective in treating menorrhagia, endometriosis
- Use up to 5 years
- Side effects: breakthrough bleeding, ovarian cysts, acne
- Cost effective (Initially, the cost of Mirena® is high, but it becomes cost-effective with extended use)
- In contrast to Mirena®, use of the copper-T IUD (Paragard®) is not associated with a decrease in bleeding. However, Paragard® is the only nonhormonal continuous-use method that does not interrupt the menstrual cycle.
Sources
- Hubacher D, Grimes DA. Noncontraceptive health benefits of intrauterine devices: a systematic review. Obstet Gynecol Surv. 2002;57:120-128.
- Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005;192:998-1004.
- Prescribing information available at: http://www.berlex.com/html/products/pi/Mirena_PI.pdf
- Prescribing information available at: http://www.paragard.com/paragard/custom_images/Prescribing_Information/pdf.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 37
Slide 37 of 90
Talking Points
Norethindrone acetate is not
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Norethindrone acetate is not a contraceptive but it often results in amenorrhea.
- Effective for treatment of menorrhagia
- One tablet daily often effective
- Up to 3 daily tablets can be used
- Indicated for treatment of endometriosis
- Side effects can include mood changes, bloating, and weight gain.
- Oral progestins are more costly than OCs or DMPA.
Source
- Irvine GA, Campbell-Brown MB, Lumsden MA, et al. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. Br J Obstet Gynecol. 1998;105;592-598.
- Prescribing information available at: http://www.aygestin.com/docs/aygestinprescribe.pdf
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 38
Slide 38 of 90

Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Danazol is not a contraceptive.
- This is an expensive option to alter menstruation.
- 100–200 mg BID
- Gonadotropin inhibitor with progestational and androgenic properties
- Indicated for endometriosis, fibrocystic breast nodularity, menorrhagia—but not contraception
- Produces amenorrhea
- Side effects may include androgenic effects (weight gain, acne), hypoestrogenic reactions (flushing, sweating, vaginal dryness, irritation)
Sources
- Stabinsky SA, Einstein M, Breen JL. Modern treatments of menorrhagia attributable to dysfunctional uterine bleeding. Obstet Gynecol Surv. 1999;54:61-72.
- Prescribing information available at: http://products.sanofi-aventis.us/danocrine/danocrine.html
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 39
Slide 39 of 90
Talking Points
GnRH analogues are not
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- GnRH analogues are not contraceptives.
- Delivery methods and dosages vary
- Indicated for endometriosis, not contraception
- Hypoestrogenic effects may be counteracted with add-back progestin and/or estrogen
- Produces amenorrhea
- This option is very expensive.
Sources
- Stabinsky SA, Einstein M, Breen JL. Modern treatments of menorrhagia attributable to dysfunctional uterine bleeding. Obstet Gynecol Surv. 1999;54:61-72.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 40
Slide 40 of 90
Talking Points
GnRH analogues are not
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- GnRH analogues are not contraceptives, but are used for these conditions.
Sources
- Olive DL. Optimizing gonadotropin-releasing hormone agonist therapy in women with endometriosis. Treat Endocrinol. 2004;3:83-89.
- Stabinsky SA, Einstein M, Breen JL. Modern treatments of menorrhagia attributable to dysfunctional uterine bleeding. Obstet Gynecol Surv. 1999;54:61-72.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 41
Slide 41 of 90
Talking Points
The most common method used
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The most common method used to regulate menstruation is to alter the way in which oral contraceptives are taken. With this method, the placebo week from the standard 21/7-day cycle is eliminated.
- 9 studies, 1,950 total patients, 42 to 336 continuous active tablets
- Of the nine studies, all but two studies used monophasic OC preparations; all but three prescribed solely 30-mcg ethinyl E2 products; one administered the OC intravaginally; and one allowed variable products to be used for variable extended cycles.
Source
- Miller L, Notter K. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 42
Slide 42 of 90
Talking Points
John Rock and Gregory
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- John Rock and Gregory Pincus, the co-inventors of the pill, believed that the pill was a natural method of birth control because it mimicked the natural course of the menstrual cycle (using a steady state of estrogen and progesterone, and then having a placebo week).
Source
- Gladwell M. John Rock’s error. The New Yorker. March 13, 2000.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 43
Slide 43 of 90
Talking Points
This study was conducted
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This study was conducted from April 1998 to April 2000 with the pill Lo/Ovral®-28.
- 90 patients were randomly assigned to Lo/Ovral®-28 (30 mg EE/300 mg NG) for either 21/7 or 42/7 cycles over four 84-day reference periods or trimesters.
- During this time, they kept diaries on bleeding, pill taking, and symptoms.
Source
- Miller L, Notter K. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 44
Slide 44 of 90
Talking Points
Of the 90 women who began
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Of the 90 women who began the study, 24 women (54.5%) on the 28-day cycle and 29 (63%) on the 49-day cycle completed the study.
- Reasons for drop-put included adverse effects, pregnancy or a desire to become pregnant, no need for contraception, or a decision not to use OCs. In addition, three patients moved and 20 were lost to follow-up.
- The two groups were similar in demographics and continuation rates.
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 45
Slide 45 of 90
Talking Points
In the first trimester, the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- In the first trimester, the number of bleeding days was significantly reduced with the extended cycle (21/7=10.9, 42/7=6.4 mean days of bleeding, P=0.005).
- In the first and fourth trimesters, the number of spotting days was similar in both schedules (28-day=4.8, 49-day=3.7 mean days, P=0.24).
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 46
Slide 46 of 90
Talking Points
There were no statistically
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- There were no statistically significant differences between reported bleeding experience and expected bleeding when women were queried at the fourth-trimester visit (P=0.56).
- With women on a 49-day cycle, 41.7% reported less than expected, 50% reported as expected, and 8.3% reported more bleeding than expected.
- With women on a 28-day cycle, 28% reported having less bleeding than expected, 67% reported as expected, and 5.6% reported more bleeding than expected.
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 47
Slide 47 of 90
Talking Points
Over the year of the study,
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Over the year of the study, women on the extended regimen used hygiene products for significantly fewer days.
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 48
Slide 48 of 90
Talking Points
Reduced cost for hygiene
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Reduced cost for hygiene products is an additional benefit of less frequent menstruation.
- Women on the extended regimen used hygiene products for significantly fewer days.
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 49
Slide 49 of 90
Talking Points
The level of women’s
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The level of women’s satisfaction with their pill schedule was reported using a five-point scale (1=not satisfied to 5=better than other methods and would recommend to other women).
- OC method satisfaction scores similar for 21/7 and 42/7 regimens (4.0 and 5.0, respectively; P = 0.13)
- At study exit, 52.4% of women who planned to continue contraceptive use wished to continue extended regimen; 16.7% of 28-day regimen subjects wished to switch to extended regimen
Source
- Miller L, Notter KM. Menstrual reduction with extended use of combination oral contraceptive pills: randomized controlled trial. Obstet Gynecol. 2001;98:771-778.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 50
Slide 50 of 90
Talking Points
Seasonale is an extended
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Seasonale is an extended oral contraceptive regimen consisting of 84 continuous days of the combination pill (30 mcg ethinyl estradiol + 150 mcg levonorgestrel) followed by a 7-day placebo or pill-free interval, resulting in a 91-day menstrual cycle.
- This regimen results in only four menstrual cycles per year.
- This study was conducted to examine the safety and efficacy of Seasonale compared with a conventional OC, Nordette-2 (30 mcg EE + 150 mcg levonorgestrel), which was administered for 13 cycles.
- Subjects were 682 healthy women aged 18–40 desiring pregnancy prevention.
- Daily compliance, bleeding/spotting, menstrual-related disorders monitored by electronic diaries
- Endometrial biopsies performed on a subset of patients
Source
- Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 51
Slide 51 of 90
Talking Points
A total of 7 patients became
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- A total of 7 patients became pregnant while in the study: 4 of 456 (0.9%) in the Seasonale group and 3 of 226 (1.3%) in the Nordette group.
- The Pearl Index is 0.60 for Seasonale and 1.78 for Nordette.
Source
- Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 52
Slide 52 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Unscheduled bleeding/spotting with Seasonale is comparable to Nordette by the 4th cycle.
Source
- Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 53
Slide 53 of 90
Talking Points
With each successive cycle,
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- With each successive cycle, days of breakthrough bleeding decreased with Seasonale. The onset of BTB also occurred later within each successive extended cycle and was of shorter duration within each successive extended cycle.
- By the last extended cycle (cycle 4), BTB was comparable between Seasonale and Nordette.
- Scheduled bleeding days with Seasonale and Nordette were also similar.
Source
- Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 54
Slide 54 of 90
Talking Points
50 women who received up to 4
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- 50 women who received up to 4 cycles of Seasonale® had endometrial biopsies before and after therapy
- No hyperplasia or significant pathology
- This study suggests that extended use of contraceptives has no adverse effect on the endometrium.
Source
- Anderson FD, Hait H, Hsiu J, et al. Endometrial microstructure after long-term use of a 91-day extended-cycle oral contraceptive regimen. Contraception. 2005;71:55-59.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 55
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Source
- Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96.
---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for
Choosing When to Menstruate: The Role of Extended Contraception in April 2003. Original funding received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the ARHP Clinical Advisory Committee for
Choosing When to Menstruate: The Role of Extended Contraception in May 2006. This slide is available at www.arhp.org/core.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 56
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Talking Points
EE 30 µg/LNG 150 µg for 84
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- EE 30 µg/LNG 150 µg for 84 days and EE 10 µg for 7 days (Seasonique™)
- 1 year, multicenter, open-label study of 708 women aged 18–40
- Formulation designed to reduce ovarian follicular activity during traditional pill-free week
- Overall failure rate: 1.27 (Pearl index)
- Cycle control and safety similar to those reported for other OC regimens
- Further studies are needed to see if the low dose of estrogen can reduce symptoms related to hormone withdrawal during what is typically the hormone-free interval.
Source
- Anderson FD, Gibbons W, Portman D. Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol. Contraception. 2006;73:229-234.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 57
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Talking Points
Thirty-two women desiring
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Thirty-two women desiring oral contraception were randomly assigned to six 28-day cycles (standard group) or 168 days without a pill-free interval (continuous group).
- The contraceptive regimen was 20 mcg EE + 100 mcg levonorgestrel taken with and without a hormone-free interval.
- As shown in the graph, total bleeding days were fewer in the continuous group, but this result did not reach statistical significance.
- However, women in the continuous group reported significantly fewer bleeding days that required sanitary protection (18.4 vs. 33.8 days) and were more likely to have amenorrhea.
Source
- Kwiecien M, Edelman A, Nichols MD, et al. Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose contraceptive: a randomized trial. Contraception. 2003;67:9-13.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 58
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Talking Points
Satisfaction with regimen was
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Satisfaction with regimen was high and similar in both groups
- For women interested in reducing the number of bleeding days requiring sanitary protection or reducing such symptoms as bloating and cramps, continuous use of OC tablets represents an appealing option
Source
- Kwiecien M, Edelman A, Nichols MD, et al. Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose contraceptive: a randomized trial. Contraception. 2003;67:9-13.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 59
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Talking Points
Miller and Hughes performed
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Miller and Hughes performed a year-long study using Alesse on a 21/7 or continuous schedule to compare bleeding profiles.
- There were no statistical differences in age, BMI, gravidity, parity, partner status, ethnicity, smoking status, education, or previous OC use.
- 79 women aged 18–45 randomly assigned to 21/7 vs. continuous 20 mg EE/100 mg LNG (Alesse®)
- 12 study cycles (336 days)
- Endometrial changes assessed with pelvic ultrasound and endometrial biopsy during cycles 1 and 9 in a sample of participants
Source
- Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653-661.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 60
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Talking Points
The continuous OC group
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The continuous OC group experienced fewer bleeding days without a statistically significant difference between the two groups in overall spotting days.
- During cycle days 1 to 21, the median number of spotting days increased initially but declined over time in the continuous OC group. The cyclic group had little change in spotting over time.
- Amenorrhea was reported by 16% of continuous OC users during cycles 1–3 and increased to 72% by cycles 10–12.
Source
- Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653-661.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 61
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Talking Points
This study observed no:
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
This study observed no:
- Pregnancies
- Adverse events (blood pressure, weight, and hemoglobin findings were similar between groups)
- Endometrial hyperplasia
Source
- Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653-661.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 62
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Talking Points
Continuous administration
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Continuous administration well tolerated by participants (dropout because of unacceptable bleeding rare)
- Significantly reduced bleeding compared with cyclic use (amenorrhea not associated with fear of pregnancy)
Source
- Miller L, Hughes JP. Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial. Obstet Gynecol. 2003;101:653-661.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 63
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Most studies of continuous-use OCs have employed monophasic OCs despite the popularity of triphasic OCs.
- This retrospective chart review involving 43 patients (603 total cycles) from four community-based physician practices suggests that successful continuous use is feasible with triphasic OCs, with few adverse effects.
- 49% of subjects said primary reason for using continuous OCs was personal preference rather than medical reasons
- Median duration of continuous use: 237 days
- 61% reported no side effects
- Most common side effect beyond day 21: BTB
- Women who had given birth at least once tended to remain on continuous use longer (398 days) than nulliparous women (212 days).
Source
- Shulman LP. The use of triphasic oral contraceptives in a continuous use regimen. Contraception. 2005;72:105-110.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 64
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This is a study of extended-use of Yasmin®, an OC that has been shown to reduce water retention, weight gain, premenstrual syndromes, and acne when used in a 21/7 regimen. Patients were culled from 10 study centers in Belgium, Denmark, Sweden, and Norway, consisting of private practices and university-affiliated clinics.
- Women were asked to keep daily diaries recording bleeding events.
- The adverse event profile was similar to that seen with the conventional 21/7 regimen.
- 40% reported complete absence of bleeding
- 60% reported shift toward less intense bleeding
- First onset of bleeding occurred median of 99 days into extended cycle
- 68.4% of women reported satisfaction with regimen
- No endometrial pathology
- At the end of the study, 42.4% of the participants said they wished to continue with the extended regimen.
Source
- Foidart J-M, Sulak PJ, Schellschmidt I, et al. The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days. Contraception. 2006;73:34-40.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 65
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Talking Points
This chart shows the
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This chart shows the percentage of all women in the study of extended use of Yasmin® reporting bleeding by study day.
- A considerable reduction in breakthrough bleeding was reported over time.
Source
- Foidart J-M, Sulak PJ, Schellschmidt I, et al. The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days. Contraception. 2006;73:34-40.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 66
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Talking Points
This study was designed to
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This study was designed to see if changing the estrogen dose or the progestin type had an influence on bleeding patterns, adverse effects, or satisfaction with combined OCs dosed continuously.
- Subjects were instructed to take the study medication continuously for 180 days.
- They were randomly assigned to one of four regimens consisting of two commercially available OCs:
20 LNG (Alesse®): 100 mcg levonorgestrel, 20 mcg ethinyl estradiol
20 NETA (LoEstrin 1/20®): 1 mg norethindrone acetate, 20 mcg ethinyl estradiol
Or, to vary the dose of estrogen while keeping the progestin type and dose constant, two novel pills:
30 LNG: 100 mcg levonorgestrel, 20 mcg ethinyl estradiol plus 10 mcg ethinyl estradiol
30 NETA: 1 mg norethindrone acetate, 20 mcg ethinyl estradiol plus 10 mcg ethinyl estradiol
Source
- Edelman AB, Koontz SL, Nichols MD, et al. Continuous oral contraceptives: are bleeding patterns dependent on the hormones given? Obstet Gynecol. 2006;107:657-665.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 67
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Talking Points
Patients in the 20 NETA and
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Patients in the 20 NETA and 30 NETA arms had significantly more days of amenorrhea than the 30 LNG arm in the second 90 days (P<0.008).
- The 30 LNG group reported more spotting days than the 20 NETA group over the entire study period (P<0.008) and the 30 NETA group for the second 90 days (P<0.008).
- Women in the 30 LNG arm reported lower levels of satisfaction with their bleeding patterns than the other groups (P=0.01 30 LNG vs. 20 NETA; P=0.001 30 LNG vs. 30 NETA).
Source
- Edelman AB, Koontz SL, Nichols MD, et al. Continuous oral contraceptives: are bleeding patterns dependent on the hormones given? Obstet Gynecol. 2006;107:657-665.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 68
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Talking Points
The authors concluded that
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The authors concluded that the addition of 10 mcg of ethinyl estradiol (EE) to a 20 mcg EE pill containing either levonorgestrel (LNG) or norethindrone acetate (NETA) did not improve bleeding patterns.
Source
- Edelman AB, Koontz SL, Nichols MD, et al. Continuous oral contraceptives: are bleeding patterns dependent on the hormones given? Obstet Gynecol. 2006;107:657-665.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 69
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Talking Points
Pharmaceutical companies are
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Pharmaceutical companies are focused on extended-use contraceptive products as a means of enhancing effectiveness of hormonal contraceptives.
- Note to speaker: In Canada, Lybrel goes under the trade name Anya. It is awaiting approval from Health Canada.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 70
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Talking Points
Two newer, longer-acting,
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Two newer, longer-acting, combination hormonal contraceptives are also potential methods for regulating menstruation and are being used off-label in extended regimens.
- The NuvaRing is approved for 3 weeks in, 1 week out use.
- In a small pharmacokinetic study on the effects of the NuvaRing after extended use (worn in the vagina for 5 weeks rather than the conventional 3 weeks), it was determined that ovulation continued to be inhibited, and there were no unfavorable safety observations.
Sources
- Bjarnadottir RI, Tuppurainen M, Killick SR. Comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol. Am J Obstet Gynecol. 2002;186:389-395.
- Zieman M. The introduction of a transdermal hormonal contraceptive (Ortho Evra/Evra). Fertil Steril. 2002;77(2 Suppl 2):S1-S2.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 71
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Talking Points
A 1-year trial was conducted
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- A 1-year trial was conducted with the vaginal ring comparing the traditional 21/7 cycle with a 49-day cycle, a 91-day cycle, and a 364-day cycle.
- All schedules were well tolerated and acceptable to women, but study completion rates were higher for the shorter cycles.
Source
- Miller L, Verhoeven CHJ, in’t Hout J. Extended regimens of the contraceptive vaginal ring. Obstet Gynecol. 2005;106:473-482.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 72
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Talking Points
Bleeding days were reduced
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Bleeding days were reduced with postponement of the withdrawal bleeding (ring-free) week, but spotting days increased.
- Spotting was defined as bleeding requiring one or less pad or tampon for the day.
- Adverse events, blood pressure, body weight, and lab findings were comparable over the four treatment groups.
Source
- Miller L, Verhoeven CHJ, in’t Hout J. Extended regimens of the contraceptive vaginal ring. Obstet Gynecol. 2005;106:473-482.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 73
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Talking Points
This 16-week trial (N=239)
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- This 16-week trial (N=239) compared the use of the norelgestromin/ethinyl estradiol transdermal contraceptive patch in a traditional regimen to an extended regimen in terms of bleeding profiles and patient satisfaction.
- Traditional 28-day regimen
- 4 consecutive cycles of 3 weekly applications, 1 patch-free week
- Extended regimen
- Weekly application 12 consecutive weeks, 1 patch-free week, 3 consecutive weekly applications
Source
- Stewart FH, Kaunitz AM, LaGuardia KD, et al. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005;105:1389-1396.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 74
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Talking Points
Extended use resulted in
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Extended use resulted in fewer median bleeding days (6 compared with 14, P<0.001), bleeding episodes (1 compared with 3, P<0.001), and bleeding or spotting episodes (2 compared with 3, P<0.001) compared with traditional cyclic use during days 1–84. Median number of bleeding or spotting days were similar between regimens (14 compared with 16, P=0.047) during this time.
- Subjects were highly satisfied with both regimens.
- Slightly more adverse events were reported with extended use than cyclic use, although this trend was not statistically significant.
Source
- Stewart FH, Kaunitz AM, LaGuardia KD, et al. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005;105:1389-1396.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 75
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Talking Points
The same study looked at
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- The same study looked at whether the extended patch regimen can reduce the incidence of estrogen-withdrawal headaches during the hormone-free interval.
- In a majority of women, the extended use of the patch reduced the total incidence of mean headache days during the hormone-free interval.
- The mean number of headache days per week when the patches were “on” was 0.63 and was 1.19 when patches were “off” (P<0.0001).
- The headache rate during the patch-on weeks in both regimens decreased significantly over the 16-week study (P=0.0002).
- During the patch-off week following 84 days of extended use, the increase in headache frequency did not exceed that seen at baseline. This suggests that withdrawal of hormonal contraception after prolonged exposure does not result in an exaggerated increase in headache frequency.
Source
- LaGuardia KD, Fisher AC, Bainbridge JD, et al. Suppression of estrogen-withdrawal headache with extended transdermal contraception. Fertil Steril. 2005;83:1875-1877.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 76
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Talking Points
An open-label randomized
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- An open-label randomized study compared the pharmacokinetics of ethinyl estradiol from the ring, patch, and pill. Analysis of area under the EE concentration versus time curve (AUC) during 21 days of treatment showed that exposure to EE in the ring group is 3.4 times lower than in the patch group (P<0.05) and 2.1 times lower than in the pill group (P<0.05). Serum EE levels of subjects showed much lower variation with the ring than with the patch or pill.
- Recent reports show higher circulating levels of estrogen with the patch than with the pill but lower peak concentrations.
- The clinical significance of this difference is unclear.
- Studies are being conducted to assess if this represents a greater risk for venous thromboembolism (VTE).
- A very small, initial epidemiology study by the Boston Collaborative Drug Surveillance Program suggests the nonfatal VTE risk is not higher with the patch than the pill; preliminary results are also similar for heart attack and stroke risk, but analyses are still ongoing. However, this study is too small to address the question posed. More data are needed to better define the safety of extended-use regimens with the patch and ring.
Sources
- http://www.orthoevra.com.html/pevr/newsroom_press_021622006.jsp?.
- van den Heuvel MW, van Bragt AJ, Alnabawy AK, et al. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72:168-174.
- Jick SS, Kaye JA, Russmann S, et al. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 µg of ethinyl estradiol. Contraception. 2006;73:223-228.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 77
Slide 77 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 78
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Talking Points
It is important to help
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- It is important to help women understand their periods and the influence of hormonal contraceptives on menstruation.
- One of the most common reasons for women stopping any hormonal contraceptive is that they are ill-informed about breakthrough bleeding: when to expect it and what it means. It may be of particular concern when the OC regimen is unfamiliar.
- Counseling can help allay patient fears and concerns and address the following issues:
- No medical rationale for monthly withdrawal bleeding while on hormonal contraceptives
- Monthly bleeding episodes: “False periods” designed to make cycle with pill seem natural
- No ovulation
- Menstrual blood does not build up with hormonal methods
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 79
Slide 79 of 90
Talking Points
No serious side effects
A
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- No serious side effects
- A dozen studies, thousands of patients
- No harmful effects on uterine lining
- Conventional pill-use data reassuring regarding breast cancer risk
- Return to fertility after discontinuation expected to be same as for conventional OCs
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 80
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Talking Points
With conventional OCs, more
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- With conventional OCs, more side effects, such as bloating, headaches, and breast tenderness, occur during the pill-free interval than during the active pill phase. Eliminating this interval can reduce some side effects.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 81
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Talking Points
Unpredictable breakthrough
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Unpredictable breakthrough bleeding similar to conventional OCs may occur
- Will lessen as body adjusts to new hormone balance
- Need to remember schedule, such as when to take pill or change patch
- May be more difficult to tell if pregnant
- Cost
- Some regimens (e.g., pills) may be more costly
- Insurance may not cover extra pill packs
- Look for other signs of pregnancy, such as breast tenderness, nausea, fatigue, etc. If necessary, pregnancy tests can be performed.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 82
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Talking Points
When to have hormone-free
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- When to have hormone-free days, if at all
- Schedule of method, such as taking OCs at the same time every day
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 83
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Talking Points
Spotting
Blood may be dark
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Spotting
- Blood may be dark brown (oxidized due to remaining in vagina longer) rather than red (blood noted with active bleeding)
- Blood may have different texture
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 84
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Talking Points
Heavy bleeding would be in
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Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Heavy bleeding would be in comparison to a woman’s previous customary bleeding
- A woman should contact her health care provider when she notices any of the following symptoms (other than missed period) that may indicate pregnancy:
Breast tenderness
Fatigue
Nausea
Frequent urination
Disclosure Text
---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
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Slide 85
Slide 85 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Talking Points
- Extending active pills/vaginal rings of hormonal regimens and reducing the number of hormone-free days may help improve quality of life in many groups of women, including those who simply choose to menstruate less frequently.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 86
Slide 86 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Full citations in speaker notes.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 87
Slide 87 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes Full citations in speaker notes.
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 88
Slide 88 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 89
Slide 89 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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Slide 90
Slide 90 of 90
Source: Association of Reproductive Health Professionals
Peer Review Date: 5/1/2006
Notes
Disclosure Text ---
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for Choosing
When to Menstruate: The Role of Extended Contraception in April 2003. Original funding
received from Wyeth through an unrestricted educational grant. Last reviewed/updated by the
ARHP Clinical Advisory Committee for Choosing When to Menstruate: The Role of Extended
Contraception in May 2006. This slide is available at www.arhp.org/core.
Creative Commons
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