• Announce program sponsors: Association of Reproductive Health Professionals (ARHP) and Planned Parenthood® Federation of America (PPFA).
• Announce that the presentation may include information that is not on product labels required by the Food and Drug Administration (FDA).
• Disclose any financial relationship(s) you have with industry.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.



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• This presentation has been peer reviewed. Your handout provides more details about the faculty.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Learning objectives for A Case-Based Approach to Addressing Hormonal Contraception.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Ideal clinical care requires both evidence-based medicine (EBM) and individualized care: evidence is necessary but insufficient. 
• Both evidence and human concern are essential for effective medical care. 
• EBM involves finding the best available evidence for a given question, then filtering that evidence through the clinician’s understanding of the woman and her preferences.
• With the vignette format, we will be focusing on particular clinical situations but must remember that individual patients have specific circumstances and deserve individualized care.

• Grimes DA. Technology follies: the uncritical acceptance of medical innovation. JAMA. 1993;269:3030-3. 


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• This presentation focuses on four cornerstones of ideal counseling on hormonal contraception.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• The interplay between hormonal contraceptives and certain clinical conditions can be challenging.
• When participants at ARHP’s annual meeting were asked about possible topics for future programs, they asked for updates on hormonal contraception, with specific emphasis on medical conditions associated with the use of hormonal contraception or the use of hormonal contraception in patients who have medical conditions.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Each year, more than 50% of all pregnancies are unintended, and almost half of unintended pregnancies occur among women who are using contraception. [Finer 2006]
• In the United States, 20% of unintended pregnancies that occur each year are among women who were using oral contraceptives. [Moreau 2007]
• About 3.1 million pregnancies are unintended each year. [Frost 2008] Thus, about 620,000 unintended pregnancies related to the use of oral contraceptive pills occur each year. [3,100,000 X 0.20 = 620,000]
• Patients may respond to side effects, especially if they are not fully explained, by making unplanned changes in their hormonal contraceptive methods, including discontinuation.
• Providers need to address the risk caused by these changes and take actions, such as greater attention to patient education, to close this gap in effectiveness.

• Finer L, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38(2):90-6.
• Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007;76(4):267-72.
• Frost JJ, Darroch JE, Remez L. Improving contraceptive use in the United States. In Brief, No. 1. New York: Guttmacher Institute; 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Women often stop taking hormonal contraception.
• 28% of women who use combined oral contraceptives (COCs) discontinue use by 6 months
• 33% to 50% discontinue COCs by 1 year
• 42% who discontinue fail to consult their health care provider
• In a broader perspective, many people fail to fill their prescriptions (of any medication) at all:
• A recent survey by the National Association of Community Pharmacists found that 31% of respondents had failed to fill a prescription.
• Ask participants: Have you ever received a prescription but failed to have it filled? Why?
• Ask participants: If you’re comfortable, talk about a time you were non-compliant yourself.

• Potter LS. Oral contraceptive compliance and its role in the effectiveness of the method. In Cramer JA, Spilker B, eds. Patient Compliance in Medical Practice and Clinical Trials. New York: Raven Press; 1991, pp. 195-207.
• Take As Directed: A Prescription Not Followed.” Research conducted by The Polling Company.™ National Community Pharmacists Association. December 15, 2006. Information reviewed by National Council of Patient Information and Education. Enhancing prescription medication adherence: a national action plan. Bethesda, MD. 2007. Available at: http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf. Accessed May 7, 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• An important tool for reducing the risk of unintended pregnancy is ensuring that both providers and patients understand the benefits and risks of hormonal contraception.
• For example, many people are unaware that the risk of venous thromboembolism (VTE) is more than twice as high in pregnant women as in women who are taking either high- or low-dose COCs. [Chang 2003; Shulman 2003]
• In addition, the risk of VTE is higher during the postpartum period than during pregnancy. For example, the risk or incidence of VTE, which includes pulmonary embolus and deep vein thrombosis, is 95.8 per 100,000 among pregnant women and 511.2 per 100,000 woman-years among postpartum women. [Heit 2005]
• Thus, the risk of VTE is (in order of increasing risk):
• A woman who is using a copper intrauterine device (IUD)
• A woman who is on low-dose COCs
• A pregnant woman
• A woman in the postpartum period

• Chang J, Elam-Evans LD, Berg CJ, Herndon J, Flowers L, Seed KA, et al. Pregnancy-related mortality surveillance—United States, 1991-1999. In: Surveillance Summaries, February 21, 2003. MMWR. 2003;52(SS-2):1-8.
• Shulman LP, Goldzieher JW. The truth about oral contraceptives and venous thromboembolism. J Reprod Med. 2003;48:930-8.
• Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, and Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005;143:697-706.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Low-dose pills, all ages –- 10–15 per 100,000 woman-years
• Desogestrel-containing pills and probably the patch – 20-30 per 100,000 woman-years
• Pregnancy, all ages — 95.8 to 172 per 100,000 woman-years
• Postpartum period --- 511.2 per 100,000 woman-years

• Finer LG, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38(2):90-6.
• Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007;76(4):267-72.
• James AH, Jamison MG, Brancazio LR, Myers ER. Venous thromboembolism during pregnancy and the postpartum period: incidence, risk factors, and mortality. Am J Obstet Gynecol. 2006;194(5):1311-5.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.



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• An essential ingredient for effective patient counseling about contraceptive options is adopting a patient-centered approach.
• Counseling a woman about her contraceptive choices must involve more than a simple recitation of scientific facts about relative efficacy. Contraceptive choice is tightly linked with a woman’s sexuality.
• For this reason, understanding a woman’s sexual history and current partner status is essential for effective counseling.
• To provide effective counseling, it’s important to ask a woman about her reproductive health plan.
• It’s also essential to recognize that a woman’s previous experience with hormonal contraception—as well as that of friends and family members—will influence her decisions.
• This presentation uses a vignette study-based approach to discuss the interplay between hormonal contraceptives and several important clinical conditions.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008.
• Association of Reproductive Health Professionals. Breaking the Contraceptive Barrier: Techniques for Effective Contraceptive Consultations. Washington, DC. 2008.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• Gathering information about a woman’s reproductive health plan can help a health care provider better tailor counseling to her needs and desires.
• Some helpful questions to ask include:
• How important is it to your personal goals to avoid pregnancy now?
• What would you do if you became pregnant now?
• What is your desired family size?
• What is your intended timing for pregnancy?
• Do you have health issues that need to be addressed before you become pregnant?


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• Focus on patient concerns—query the patient about her agenda for the visit and her family-planning goals.
• Ask about her preferences for contraception—find out which options are acceptable to her.
• Collect information for a personal profile—query about facts that may influence the suitability of her preferences (e.g., lifestyle, personal factors, health history, previous experience with hormonal contraception).
• Discuss considerations for preferred method(s)—provide information about benefits, side effects, and risk of the preferred method(s).
• Support the woman in making a final decision that works for her—remember to provide supporting information and contact information she may need for any later questions and for follow-up care.
• A Health Care Team Tool Kit that contains more information and aids to support these components is available through ARHP and PPFA. Please contact ARHP’s education department for more information.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008. 


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• This vignette involves a 20-year-old college sophomore who presents for emergency contraception (EC).
• She has had one partner for the past year.
• She reports having unprotected intercourse on day 15 of her menstrual cycle, 12 hours previously.
• She had started using COCs 6 months before but had switched to condoms after 4 months because of annoyance with spotting.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• The last option is correct.
• Sofia’s spotting while she was taking COCs could have been caused by missed pills. Patients may not equate a missed dose with spotting, because the spotting is often delayed, occurring 1–2 days after the missed dose.
• The provider should tell Sofia what to expect in terms of bleeding patterns after emergency contraception. The first menstrual cycle after use of EC is usually shorter than normal but with a longer duration of bleeding. [Raymond 2006] If the menstrual cycle has not begun within 7 days, Sofia or her provider should test for pregnancy.

• Raymond EG, Goldberg A, Trussell J, Hays M, Roach E, Taylor D. Bleeding patterns after use of levonorgestrel emergency contraceptive pills. Contraception. 2006;73(4):376-81.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Ask about any concerns she may have about EC
• Discuss the effectiveness of desired contraceptive methods
• Suggest ways to improve her adherence for ongoing methods, such as taking a COC before she brushes her teeth each morning


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• Sofia’s menses start 4 days after EC and are slightly heavier and longer in duration than usual.
• She chooses to begin using a contraceptive patch to avoid the need for daily pill-taking.
• Her provider counsels her on expected bleeding patterns with the contraceptive patch.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Unwanted bleeding is a common reason for discontinuation of COCs. [Nelson 2007]
• Missed pills are one of the most common causes of spotting and bleeding in COC users. [Nelson 2007]
• Without education about this side effect in advance, women are especially likely to stop using COCs. This education should include information about the normal menstrual cycle and bleeding patterns when they take hormonal contraception.
• Bleeding is common when hormonal contraception is started or changed, especially with progestin-only methods. [Nelson 2007; Raymond 2007]
• Women who discontinue COCs due to unwanted bleeding without protection from another method are at risk for undesired pregnancy.
• Women who do not understand these concepts are at risk for stopping methods that they might be satisfied with if:
• They understood the expected and unexpected bleeding patterns and
• Were aware that the amenorrhea sometimes associated with use of COCs is not dangerous.

• Nelson A. Combined oral contraceptives. In: Hatcher RA, Trussell J, Nelson AL, Cates W Jr., Stewart FH, and Kowal D, editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
• Raymond EG. Progestin-only pills. In: Hatcher RA, Trussell J, Nelson AL, Cates W Jr., Stewart FH, and Kowal D, editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
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Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• COCs, the vaginal ring, and the contraceptive patch are associated with similar bleeding patterns. Initial use is associated with spotting or breakthrough bleeding in 30%–to 50% of COC users. [Nelson 2007] However, by 3 months, 70%–90% of COC users experience no spotting or breakthrough bleeding. [Nelson 2007] All three methods provide cycle control with regular menses, with the exception of the continuous-use COC regimen. [Nelson 2004; Hatcher 2004] For absence of bleeding, the rate varies with different formulations of COCs but generally increases with duration of use. [Hatcher 2004a]
• Progestin-only pills are associated with irregular menses, spotting, and breakthrough bleeding. [Raymond 2007] Their use is less likely than other progestin-only methods to result in absence of bleeding. [Hatcher 2004b] In one study, just under 8% of women who used progestin-only pills for at least 6 months had absence of bleeding. [Broome 1990]
• Initial use of depot medroxyprogesterone acetate (DMPA) often is associated with spotting or breakthrough bleeding. [Goldberg 2007] Continued use leads to absence of bleeding in most women. After 1 year of use, 40%–50% of women experience amenorrhea; 80% experience amenorrhea after 5 years. [Goldberg 2007] Counseling about bleeding increases continuation rates. [Canto De Cetina 2001]
• Implanon use is associated with spotting or bleeding that lessens over time. The highest number of days with bleeding or spotting and the highest number of bleeding-spotting episodes occur during the first 3 months of use. [Funk 2005] Absence of bleeding occurs in less than 20% of Implanon users by 24 months. [Funk 2005]

• Nelson A. Combined oral contraceptives. In: Hatcher RA, Trussell J, Nelson AL, Cates W Jr., Stewart FH, and Kowal D, editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
• Nelson A, Stewart FH. Menopause. In: Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W Jr., Guest F, et al., editors. Contraceptive Technology. 18th ed. New York, NY: Ardent Media, Inc.; 2004.
• Raymond EG. Progestin-only pills. In: Hatcher RA, Trussell J, Nelson AL, Cates W Jr., Stewart FH, and Kowal D, editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
• Hatcher RA, Nelson A. Combined hormonal contraceptive methods. In: Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W Jr., Guest F, et al., editors. Contraceptive Technology. 18th ed. New York, NY: Ardent Media, Inc.; 2004. [Hatcher 2004a]
• Hatcher RA. Depo-Provera injections, implants, and progestin-only pills (minipills). In: Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W Jr., Guest F, et al., editors. Contraceptive Technology. 18th ed. New York, NY: Ardent Media, Inc.; 2004. [Hatcher 2004b]
• Goldberg AB, Grimes DA. Injectable contraceptives. In: Hatcher RA, Trussell J, Nelson AL, Cates W Jr., Stewart FH, and Kowal D, editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
• Funk S, Miller MM, Mishell DR Jr, et al. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71(5):319-26.
• Broome M, Fotherby K. Clinical experience with the progestogen-only pill. Contraception. 1990;42:489-95.
• Canto De Cetina TE, Canto P, Ordoñez Luna M. Effect of counseling to improve compliance in Mexican women receiving depot-medroxyprogesterone acetate. Contraception. 2001;63(3):143-6.
• Mishell DR Jr, Kletzky OA, Brenner PF, et al. The effect of contraceptive steroids on hypothalamic-pituitary function. Am J Obstet Gynecol. 1977;128(1):60-74.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Breakthrough bleeding and spotting result from thinning of the uterine lining caused by the administration of progestins early in the cycle. Over time, the endometrium adjusts to the exogenous hormones, and bleeding and spotting often resolve.
• To manage breakthrough bleeding that continues after the 3rd month of use: [Hatcher 2004]
• Check for missed or mistimed pills.
• Rule out pregnancy.
• Rule out infection, including cervicitis and vaginitis.
• Review medications that affect metabolism of hormones (e.g., anticonvulsants, rifampin, St. John’s wart).
• Evaluate for gastrointestinal disturbances that could reduce absorption. Remember to ask about:
• Malabsorption syndromes
• Gastric bypass surgery
• Gastric banding procedures
• Recent illness with vomiting or diarrhea
• Use of medications that reduce gastrointestinal absorption, such as orlistat (Xenical®, alli®).
Anecdotally, clinicians have noticed reduced effectiveness under these circumstances.

• Change to another formulation:
• For bleeding before completion of active pills, increase the progestin component.
• For spotting that continues after withdrawal bleeding, increase the estrogen component or decrease progestin in the early pills.
• For women with mid-cycle spotting or bleeding, increase both estrogen and progestin.
• Change the delivery route from oral to transdermal or intravaginal. A Cochrane systematic review published in 2008 concludes that women who use a vaginal ring often have fewer bleeding problems than COC users. [Lopez 2008] Similarly, detailed data on bleeding patterns are not available for the patch compared with COCs or the ring compared with the patch. However, two comparative studies of the patch and COCs showed similar breakthrough bleeding or spotting. Regardless of studies to date, a change in delivery route may improve the bleeding profile of a woman who experiences an annoying bleeding pattern. In other words, a trial switch to another delivery method is just as valid as adding estrogen or progestin to the hormonal formulation or adding NSAIDs (described below). Compared with COC users, women who use a vaginal ring reported less nausea, irritability, and depression. However, ring users had more vaginitis and leukorrhea compared with COC users. Compared with COC users, patch users were more likely to report breast discomfort, dysmenorrhea, nausea, and vomiting. 
• Continue the current COC formulation, adding NSAIDs or supplemental estrogen to manage the breakthrough bleeding and spotting. [Roy 2004; Lethaby 2002; Speroff 2005]

• Hatcher RA, Nelson A. Combined hormonal contraceptive methods. In: Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W Jr., Guest F, et al., editors. Contraceptive Technology. 18th ed. New York, NY: Ardent Media, Inc.; 2004.
• Roy SN, Bhattacharya S. Benefits and risks of pharmacological agents used for the treatment of menorrhagia. Drug Saf. 2004;27:75-90.
• Lethaby A, Augood C, Duckitt K. Nonsteroidal anti-inflammatory drugs for heavy menstrual bleeding. Cochrane Database Syst Rev. 2002;CD000400.
• Speroff L, Darney PD. Oral contraception. In: A Clinical Guide for Contraception. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. Chapter 2.
• Lopez LM, Grimes DA, Gallo MF, Schultz KF. Skin patch and vaginal ring versus combined hormonal contraceptives for contraception. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003552.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• This vignette involves a 30-year-year old Latina who is a healthy non-smoker with normal blood pressure.
• She’s married and has two children; the youngest is now 6 months old. She and her husband would like a third child in the future.
• Maria gained 40 pounds in the last 3 years, since her first pregnancy. She now weighs 180 pounds and is 5 feet, 5 inches tall.
• Her BMI is 30.9.
• She works in a fairly sedentary job as a manager in an insurance company.
• She would like to switch to a contraceptive method that has greater effectiveness than condoms.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• Option three is correct.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Overweight and obesity are defined by the Body Mass Index (BMI), which is calculated based on height and weight in pounds or kilograms.
• On the basis of these definitions, with a BMI of 30.9, Maria is obese. Before the 40-pound weight gain, Maria was in the normal range for weight, with a BMI of 23.3.

• National Institutes of Health. Calculate Your Body Mass Index. Available at: www.nhlbisupport.com/bmi/. Accessed March 24, 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• BMI calculators are available on the Internet:
• National Institutes of Health: http://www.nhlbisupport.com/bmi/
• Centers for Disease Control and Prevention: http://www.cdc.gov/nccdphp/dnpa/bmi/
• Mayo Clinic: http://www.mayoclinic.com/health/bmi-calculator/NU00597

• National Institutes of Health. Calculate Your Body Mass Index. Available at: www.nhlbisupport.com/bmi/. Accessed March 24, 2008.


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Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• Several studies have suggested that COCs may show reduced contraceptive efficacy in obese women.
• As shown in this slide, a 2005 case-control study by Holt and colleagues found:
• A relative risk of failure of 1.6 for women with BMI >27.3 and a relative risk of failure of 1.4 among women who weighed 165 pounds or more.
• Risk was higher among users of low-dose COCs.
• This risk translates into an absolute risk of an additional two to four pregnancies per 100 woman-years of use for overweight women compared with women of normal weight.

• Holt VL, Scholes D, Wicklund KG, Cushing-Haugen KL, and Daling JR. Body mass index, weight, and oral contraceptive failure risk. Obstet Gynecol. 2005;105(1):46-52.

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• Most studies, including this one, suggest a modest increase in risk of pregnancy among obese COC users compared with COC users of normal weight.

• Brunner LR, Hogue CJ. The role of body weight in oral contraceptive failure: results from the 1995 national survey of family growth. Ann Epidemiol. 2005;15:492-9.

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Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• This slide compares typical failure rates, defined as the percentage of women who experience an unintended pregnancy during the 1st year of typical use in the United States.
• A typical failure rate for obese women who use COCs (13%, rounded from 12.8; see slide 30 for calculations) is higher than that of highly effective methods, such as hormonal implant, sterilization, DMPA, copper IUD, and the levonorgestrel-releasing intrauterine system (LNg-IUS), but lower than that of moderately effectively methods, such as of condoms and diaphragms.
• For obese women who do not want one of the long-term, highly effective methods, COCs remain an effective option for preventing pregnancy.

• Trussell J. Choosing a contraceptive: efficacy, safety, and personal considerations. In: Hatcher RA, Trussell J, Nelson A, et al., editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.

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• The effectiveness of COCs may be reduced among obese women, especially when they use COCs that have lower doses of estrogen.
• Proposed mechanisms include effect of obesity on steroid hormone metabolism or sequestration of hormones in fat, which could alter the effectiveness of hormonal contraceptives. [Holt 2005]
• The increase in absolute risk of contraceptive failure is probably modest:
• The increase in risk of pregnancy attributable to obesity is 2-4 pregnancies per 100 woman-years, which represents a 50% increase (from 8% to 12%) in contraceptive failure in the first year of use of COCs in the United States. [Holt 2005; Trussell 2004]
• Providers must help obese women weigh the risks associated with pregnancy with the risk (e.g., of VTE) of using COCs.
• In the World Health Organization (WHO) criteria for initiating COCs, obesity is considered category 2, meaning that the advantages of using the method generally outweigh the theoretical or proven risks. [WHO 2004] The category 2 is based on the increased risk of VTE with obesity, not concerns about reduced effectiveness.
• In contrast, UK criteria for initiating COCs designate a higher risk category to women with BMI >35. The UK designation has been challenged by researchers who believe that the benefits of COCs for women with a BMI >35 outweigh the risks, although data are unavailable to assess risk in women with a BMI > 40. [UK Medical Eligibility Criteria; Trussell 2008]

• Trussell J. The essentials of Contraception: Efficacy, Safety, and Personal Considerations. In: Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W Jr., Guest F, et al., editors. Contraceptive Technology. 18th ed. New York, NY: Ardent Media, Inc.; 2004.
• World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. 2004. Available at: http://www.who.int/reproductive-health/publications/mec/summary.html. Accessed March 20, 2008.
• Holt VL, Scholes D, Wicklund KG, Cushing-Haugen KL, and Daling JR. Body mass index, weight, and oral contraceptive failure risk. Obstet Gynecol. 2005;105(1):46-52.
• UK Medical Eligibility Criteria for Contraceptive Use (UK MEC 2005/2006). London: Faculty of Family Planning and Reproductive Health Care; 2006.
• Trussell J, Guthrie KA, Schwarz EB. Much ado about little: obesity, combined hormonal contraceptive use and venous thrombosis. Contraception. 2008;77(3):143-6.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• There is no increased risk of contraceptive failure with DMPA. [Jain 2004]
• There may be increased risk of failure with the contraceptive patch. [Zieman 2002]
• Trials with Implanon included only women >130% of ideal body weight. [Croxatto 1999; Funk 2005]
• There have been few contraceptive failures with the vaginal ring, and BMI of these women was not reported. [Oddsson 2005; Ahrendt 2006]

• Jain J, Jakimiuk AJ, Bode FR, Ross D, and Kaunitz AM. Contraceptive efficacy and safety of DMPA-SC. Contraception. 2004;70:269-75.
• Croxatto HB, Urbancsek J, Massai R, Coelingh Bennink H, van Beek A. A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study Group. Hum Reprod. 1999;14:976-81.
• Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt A, et al. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71:319-26.
• Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, and Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002;77(2 Suppl 2):S13-8.
• Oddsson K, Leifels-Fischer B, de Melo NR, Wiel-Masson D, Benedetto C, Verhoeven CH et al. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception. 2005;71:176-82.
• Ahrendt HJ, Nisand I, Bastianelli C, Gomez MA, Gemzell-Danielsson K, Urdl W, et al. Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 microg of ethinylestradiol and 3 mg of drospirenone. Contraception. 2006;74:451-7.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Other contraceptive options that can be considered for obese women include copper IUDs, the levonorgestrel-releasing intrauterine system, barrier methods, and sterilization.

• Trussell J. Contraception for Obese Women [slide presentation]. Atlanta (GA): Contraceptive Technology; 2007.

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Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• Maria remains a candidate for COCs despite her obesity.
• As part of a reproductive health plan, her provider should ask about the desired timing of her next pregnancy (e.g., “When would you like to become pregnant?”), to support Maria in making her decision about the best option, based on her goals and needs.
• Other combined hormonal contraceptives also remain options.
• The copper IUD and LNg-IUS are other options she could consider.
• Given her plans for future childbearing, sterilization is not an option.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• The provider should review Maria’s contraceptive options with her and also counsel and support interventions to help Maria lose weight.
• National guidelines recommend an initial goal of 10% of baseline body weight, to be lost at a rate of 1 to 2 pounds per week. [NIH Guidelines 1998]
• To help Maria lose weight, the clinician should provide information and support for a weight-reduction and exercise plan. Maria should have a follow-up visit scheduled to encourage continued weight loss or provide referrals (e.g., nutritionist) as needed.
• The clinician also should encourage Maria to incorporate other healthy lifestyle changes, such as seeking routine periodic screening (blood pressure, breast self-exam, mammogram, cervical cytology, lipid screen and fasting glucose to rule out metabolic syndrome, etc.), routine seat-belt use, and avoidance of second-hand smoke. If Maria had been a smoker, the clinician should have encouraged and supported smoking cessation.

• National Institutes of Health. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. 1998. Available at: www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed March 4, 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Both obesity and COC use increase the risk of venous thromboembolism.
• There appears to be a threshold effect, with an increase in absolute risk at a BMI >35 and an almost doubling of absolute risk between a BMI of 30–34 and a BMI of >35. [Stein 2005; Abdollahi 2003; Nightingale 2000; Trussell 2008]

• Stein PD, Beemath A, Olson RE. Obesity as a risk factor in venous thromboembolism. Am J Med. 2005;118:978-80.
• Abdollahi M, Cushman M, Rosendaal FR. Obesity: risk of venous thrombosis and the interaction with coagulation factor levels and oral contraceptive use. Thromb Haemost. 2003;89:493-8.
• Nightingale AL, Lawrenson RA, Simpson EL, et al. The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives. Eur J Contracept Reprod Health Care. 2000;5:265-74.
• Trussell J, Guthrie KA, Schwarz EB. Much ado about little: obesity, combined hormonal contraceptive use and venous thrombosis. Contraception. 2008;77(3):143-6.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Provide information on the risks associated with obesity and pregnancy to help inform her decision about contraception. Include side effects, relative and absolute risk of adverse events, non-contraceptive benefits, convenience, and other factors she deems important. Explain that both obesity and hormonal contraception increase the risk of VTE.
• Encourage practical steps she can take to increase exercise and adopt a healthier diet.
• Review her reproductive health plan in light of her weight goals (e.g., to set a goal for achieving a healthy weight before another pregnancy).
• Schedule or encourage her to schedule follow-up visits for preventive health care.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• This vignette involves a 40-year-year old Caucasian woman who is a healthy non-smoker.
• She has used DMPA since the birth of her third child, 10 years ago.
• She has no vasomotor symptoms or other signs of menopause.
• She’s pleased with the method but concerned by recent media reports about bone loss associated with DMPA use.

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Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• Reductions in bone mineral density (BMD) have been associated with DMPA use. Similar to the case with lactation, these reductions are reversible. [Kalkwarf 1995; Orr-Walker 1998; Pettiti 2000; Scholes 2004]
• Studies of the bone effects of DMPA are based on surrogate markers (e.g., BMD measured by X-ray absorptiometry) rather than a true clinical endpoint (e.g., fracture rate). In contrast, trials of osteoporosis therapies are based on fracture rate because of the known limitations in sensitivity and specificity of surrogate markers of bone loss. [Seeman 2007]
• In general, clinicians have been concerned that two groups of women might be at higher risk of reductions in BMD while using DMPA: (a) adolescents who have not yet reached peak bone mass and (b) women who may be starting to lose bone mass due to approaching menopause. There is no evidence of increased fracture risk among adolescents and women of all ages who use DMPA. [Kaunitz 2006; Kaunitz 2008]
• It is difficult to predict when a particular woman will experience menopause. Elevated follicle-stimulating hormone (FSH) and luteinizing hormone (LH) are indicative of menopause; however, these values are suppressed in women who take DMPA. [Juliato 2007]
• Several studies have shown that DMPA-related reductions in BMD are reversible. [Clark 2006; Cromer 2008, Kaunitz 2006; Kaunitz 2008] In women who are not approaching menopause, BMD reductions are presumably reversible before the time of bone loss associated with menopause. For this reason, assessment of bone mineral density in these women is not necessary.
• Women who are not perimenopausal and do not have major risk factors for osteoporosis, such as Elizabeth, can continue using DPMA.
• When Elizabeth transitions into menopause, management options are less clear. As yet, there is no definitive guidance about DPMA use during the approach to menopause.

• Clark MK, Sowers M, Levy B, Nichols S. Bone mineral density loss and recovery during 48 months in first-time users of depot medroxyprogesterone acetate. Fertil Steril. 2006;86:1466-74.
• Cromer BA, Bonny AE, Stager M, Lazebnik R, Rome E, Ziegler J et al. Bone mineral density in adolescent females using injectable or oral contraceptives: a 24-month prospective study. Fertil Steril. 2008 Jan 25 [Epub ahead of print]
• Juliato CT, Femandes A, Marchi NM, Castro S, Olivotti B, and Bahamondes L. Usefulness of FSH measurements for determining menopause in long-term users of depot medroxyprogesterone acetate over 40 years of age. Contraception. 2007;76:282-6.
• Kalkwarf HJ, Specker BL. Bone mineral loss during lactation and recovery after weaning. Obstet Gynecol. 1995;86:26-32.
• Kaunitz AM, Miller PD, Rice VM, Ross D, McClung MR. Bone mineral density in women aged 25-35 years receiving depotmedroxyprogesterone acetate: recovery following discontinuation. Contraception. 2006;74:90-9.
• Kaunitz AM, Arias R, McClung M. Bone density recovery after depot medroxyprogesterone acetate injectable contraception use. Contraception. 2008; 77:67-76.
• Orr-Walker BJ, Evans MC, Ames RW, Clearwater JM, Cundy T, Reid IR. The effect of past use of the injectable contraceptive depot medroxyprogesterone acetate on bone mineral density in normal post-menopausal women. Clin Endocrinol. 1998;49:615-18.
• Petitti DB, Piaggio G, Mehta S, Cravioto MC, Meirik O. Steroid hormone contraception and bone mineral density: a cross-sectional study in an international population. The WHO Study of Hormonal Contraception and Bone Health. Obstet Gynecol. 2000;95:736-44.
• Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. The association between depot medroxyprogesterone acetate contraception and bone mineral density in adolescent women. Contraception. 2004;69:99-104.
• Seeman E. Is a change in bone mineral density a sensitive and specific surrogate of anti-fracture efficacy? Bone. 2007;41:308-17.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Studies of the bone effects of DMPA are based on surrogate markers (e.g., BMD measured by X-ray absorptiometry) rather than a true clinical endpoint (e.g., fracture rate). In contrast, trials of osteoporosis therapies are based on fracture rate because of the known limitations in sensitivity and specificity of surrogate markers of bone loss. [Seeman 2007]
• Testing is not generally indicated for evaluating bone status in women who are using DMPA.
• No standards currently exist for evaluating BMD in pre-menopausal women.

• Seeman E. Is a change in bone mineral density a sensitive and specific surrogate of anti-fracture efficacy? Bone. 2007;41:308-17.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Provide information about bone loss.
• Discuss benefits and risks of various options.
• Ask about any concerns she may have about menopause.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• This vignette involves Susan, a 52-year-old married non-smoker.
• She’s had irregular menses since age 50, with vasomotor symptoms for about 9 months.
• Night sweats are disrupting her sleep to the extent that her work as a real estate agent is affected.
• She relies on condoms for contraception.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Obesity and sedentary lifestyle have been shown to increase vasomotor symptoms. Strategies to exercise regularly and maintain a healthy weight may help reduce hot flashes. [NAMS 2004] Other strategies include altering ambient temperature as needed, dressing in layers, and avoiding triggers such as spicy foods.
• Systemic hormonal therapy with estrogen alone (for women who have had a total hysterectomy) or an estrogen-progestin combination (for women who have an intact uterus) is the “most consistently effective therapy for hot flashes and night sweats,” according to a 2005 National Institutes of Health consensus statement on the treatment of menopause-related symptoms. [NIH 2005] Use of estrogen therapy and estrogen-progestin therapy should be limited to the shortest duration consistent with treatment goals, benefits, and risks for the individual woman. For women who require contraception, COCs or systemic progestogens provide an effective alternative.
• Systemic progestogens, such as DMPA, MPA, and megestrol acetate, have been shown to improve vasomotor symptoms. [NAMS 2004]
• In contrast, topical progestogens have not been shown to be helpful. [NAMS 2004]

• North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause. 2004;11(1):11-33.
• National Institutes of Health. NIH State-of-the-Science Conference Statement on Management of Menopause-Related Symptoms. 2005. Available at: http://consensus.nih.gov/2005/2005MenopausalSymptomsSOS025PDF.pdf. Accessed February 22, 2008.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.



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• Lifestyle changes to reduce hot flashes
• Trial of COCs
• COC pills can help stabilize hormone levels, which naturally fluctuate during the perimenopausal period, and reduce vasomotor symptoms. [Nelson 2004] In addition, there is some evidence that COC use can help slow the loss of bone mass common to perimenopause. [Kuohung 2000]
• It is worth noting that the data on relief of vasomotor symptoms have been for COCs. However, the general knowledge base for the combined-hormone vaginal ring and contraceptive patch suggest that these methods should provide relief also and should be offered as options.
• If Susan’s FSH level had been elevated, indicating a menopausal status, hormone replacement therapy would have been an option and would have provided a lower dose of estrogen than COCs.
• Other interventions, as determined by history and physical findings.

• Nelson AL, Stewart FH. Menopause and perimenopausal health. In: Hatcher RA, Trussell J, Nelson A, et al., editors. Contraceptive Technology. 19th ed. New York, NY: Ardent Media, Inc.; 2007.
• Kuohung W, Borgatta L, Stubblefield P. Low-dose oral contraceptives and bone mineral density: an evidence-based analysis. Contraception. 2000;61(2):77-82.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Focus on patient concerns—find out which aspects of menopausal symptoms are causing the most disruption.
• Ask about current contraceptive choice—is she satisfied with condoms? Is there a need for higher effectiveness? How does she feel about hormonal contraception?
• Provide information on the relative risks and health benefits of COCs and other combined-hormone methods, such as the patch or ring.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• This vignette involves Marianna, a 42-year-old mother of two who divorced 3 years ago.
• She works full time and provides occasional care to her ailing parents, who are in an assisted living facility in the next town.
• She’s been with her current partner for the past year—her first sexual relationship since the divorce.
• She reports having had “libido problems” for the past 6 months, since she started using COCs.
• She is a healthy non-smoker.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• Sexual dysfunction is multifaceted, so understanding the exact nature of the problem must be the first step.
• It would be premature to prescribe topical testosterone, especially in a premenopausal woman who has intact ovaries, or to switch COCs. We’ll discuss this and the relationship between COCs and sexual dysfunction in a moment.
• Sex counseling may be indicated in the future, after an in-depth inquiry about the “libido problem.”


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• Sexual dysfunction in women may be caused by a multitude of factors.
• The first step in evaluating sexual dysfunction is a complete sexual history and assessment of the exact nature of the dysfunction.
• It’s important to distinguish diminished desire for sexual contact, difficulties with arousal and/or lubrication, and difficulty or inability to achieve orgasm.
• In women who report pain with sexual contact, it’s also important to determine the precise location and timing of the pain.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008.
• Association of Reproductive Health Professionals. Women’s Sexual Health in Midlife and Beyond. Washington, DC. 2005.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
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• When evaluating diminished sexual interest in a perimenopausal woman, it is important to consider the range of possible causes rather than assume the culprit is the hormonal changes associated with perimenopause.
• The provider should ask Marianna whether she experiences pain with sexual contact, and if so, the location and timing of the pain:
• Pain that occurs before intercourse could be caused by external lesions.
• Pain during intercourse may be due to vaginal dryness.
• Pain that occurs after intercourse points to a mechanical problem, such as endometriosis.
• Erectile dysfunction in her partner, due to impotence or inability to maintain an erection for a sufficient time, and sleep deprivation are other possible causes of diminished sexual interest.
• After questioning Marianna about potential causes for diminished sexual interest, her provider should perform a pelvic exam to look for evidence of one of these causes.

• Expert Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception. 2008.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• COC use is associated with changes in serum androgens. Specifically, women who take COCs generally have higher levels of sex hormone-binding globulin (SHBG) and lower levels of dehydroepiandrosterone-sulfate (DHEA-S), and free and total testosterone. [Warnock 2006; Graham 2007]
• These androgen reductions are responsible for the improvement in acne associated with some COCs.
• However, checking serum levels of these hormones will not help clinical management.

• Warnock JK, Clayton A, Croft H, Segraves R, Biggs FC. Comparison of androgens in women with hypoactive sexual desire disorder: those on combined oral contraceptives (COCs) vs. those not on COCs. J Sex Med. 2006;3:878-82.
• Graham CA, Bancroft J, Doll HA, Greco T, Tanner A. Does oral contraceptive-induced reduction in free testosterone adversely affect the sexuality or mood of women? Psychoneuroendocrinology. 2007;32:246-55.

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Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• The effect of COCs on sexual functioning is not entirely clear.
• In one study of 61 healthy women, a reduction in serum androgens associated with COC use was associated with reduced frequency of sexual thoughts. [Graham 2007] However, some of the women had no loss in sexual interest despite relatively large reductions in serum androgens. Overall, there was no evidence that use of COCs had a negative effect on enjoyment of sexual activity with a partner.
• Also, because the normal range of free testosterone in women is large, it is difficult to detect a statistically significant change in the metric and to determine whether free testosterone at the low range of normal is responsible for symptoms of sexual dysfunction.
• A study of more than 1,000 women found no correlation between low free or total testosterone and low sexual function scores and also found that the majority of women with low DHEA-S did not have low sexual function. [Davis 2005]
• Alternatively, some providers have found that patients who take COCs report improved sexual functioning, possibly due to the “add-back” estrogen component they contain.

• Davis SR, Davison SL, Donath S, Bell RJ. Circulating androgen levels and self-reported sexual function in women. JAMA. 2005;294:91-6.
• Graham CA, Bancroft J, Doll HA, Greco T, Tanner A. Does oral contraceptive-induced reduction in free testosterone adversely affect the sexuality or mood of women? Psychoneuroendocrinology. 2007;32:246-55.

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• Large, well-controlled studies of androgen therapy for sexual dysfunction in women have not been conducted. Available data are from small studies, generally of specific populations.
• Testosterone has been shown to improve sexual desire and arousal in women who have undergone surgical menopause [Sherwin 1985] and to improve sexual activity, pleasure, and orgasm in women who have had bilateral oophorectomy. [Shifren 2000]
• A number of small studies have shown that sexual function improved in postmenopausal women who were treated with both testosterone and estrogen. [Watts 1995; Lobo 2003; Sarrel 1998]
• A small trial (32 women) showed that testosterone improved sexual function in premenopausal women who had low serum testosterone and low sexual desire. [Goldstat 2003]
• Short-term use of testosterone has been associated with alopecia, acne, and hirsutism. [Phillips 1997] The long-term effects of testosterone use, including cardiovascular effects, are not yet known.

• Sherwin BB, Gelfand MM. Sex steroids and affect in the surgical menopause: a double-blind, cross-over study. Psychoneuroendocrinology. 1985;10(3):325-35.
• Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000;343(10):682-8.
• Watts NB, Notelovitz M, Timmons MC, Addison WA, Wiita B, Downey LJ. Comparison of oral estrogens and estrogens plus androgen on bone mineral density, menopausal symptoms, and lipid-lipoprotein profiles in surgical menopause. Obstet Gynecol. 1995;85(4):529-37.
• Lobo RA, Rosen RC, Yang HM, Block B, Van Der Hoop RG. Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire. Fertil Steril. 2003;79(6):1341-52.
• Sarrel P, Dobay B, Wiita B. Estrogen and estrogen-androgen replacement in postmenopausal women dissatisfied with estrogen-only therapy. J Reprod Med. 1998;43(10):847-56.
• Goldstat R, Briganti E, Tran J, Wolfe R, Davis SR. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women. Menopause. 2003;10(5):390-8.
• Phillips E, Bauman C. Safety surveillance of esterified estrogens-methyltestosterone (Estratest and Estratest HS) replacement therapy in the United States. Clin Ther. 1997;19(5):1070-84.

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Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
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• For this patient, a trial off COCs might be helpful.
• Marianna might want to pursue help with care-giving responsibilities to reduce the stress associated with caring for her ailing parents.
• Stress-reduction techniques might help reduce the general level of stress in her life.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Ask her to outline her concerns.
• Collect information on lifestyle to evaluate causes of sexual dysfunction (e.g., sleep patterns, daily stressors, exercise routine, availability of her partner).
• If indicated by history, suggest evaluation of her partner.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
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• This vignette involves Jessica, a 25-year-old graduate student who is known to have a breast cancer susceptibility gene (BRCA) mutation.
• She is healthy and a non-smoker.
• Her mother was diagnosed with breast cancer at age 39.
• Jessica currently uses condoms for contraception.
• She has never used hormonal contraception but would like a more effective method.

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• The second option is correct.

• Milne RL, Knight JA, John EM, Dite GS, Balbuena R, Ziogas A, et al. Oral contraceptive use and risk of early-onset breast cancer in carriers and noncarriers of BRCA1 and BRCA2 mutations. Cancer Epidemiol Biomarkers Prev. 2005;14(2):350-6.

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• Certain mutations of the BRCA1 and BRCA2 genes are associated with an increased risk of both breast and ovarian cancer. [Miki 1994; Wooster 1995]
• The lifetime risk of breast cancer in a woman with either mutation is 60%–85%. [Brose 2002; Thompson 2002]
• Characteristics that increase the likelihood of having a BRCA mutation include: [Frank 2002; Srivastava 2001; Shattauck-Eidens 1997; Couch 1997]
• Young age at breast cancer diagnosis
• Bilateral breast cancer
• Family history of both breast and ovarian cancer
• Multiple cases of breast cancer in a family
• Both breast and ovarian cancer in a family
• Ashkenazi Jewish heritage

• Miki Y, Swensen J, Shattuck-Eidens D, Futreal PA, Harshman K, Tavtigian S, et al. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science. 1994;266:66-71.
• Wooster R, Bignell G, Lancaster J, Swift S, Seal S, Mangion J, et al. Identification of the breast cancer susceptibility gene BRCA2. Nature. 1995;378:789-92.
• Brose MS, Rebbeck TR, Calzone KA, Stopfer JE, Nathanson KL, Weber BL. Cancer risk estimates for BRCA1 mutation carriers identified in a risk evaluation program. J Natl Cancer Inst. 2002;94:1365-72.
• Thompson D, Easton DF. Cancer incidence in BRCA1 mutation carriers. J Natl Cancer Inst. 2002;94:1358-65.
• Frank TS, Deffenbaugh AM, Reid JE, Hulick M, Ward BE, Ligenfelter B, et al. Clinical characteristics of individuals with germline mutations in BRCA1 and BRCA2: analysis of 10,000 individuals. J Clin Oncol. 2002;20:1480-90.
• Srivastava A, McKinnon W, Wood ME. Risk of breast and ovarian cancer in women with strong family histories. Oncology (Williston Park). 2001;15:889-902.
• Shattuck-Eidens D, Oliphant A, McClure M, McBride C, Gupte J, Rubano T, et al. BRCA1 sequence analysis in women at high risk for susceptibility mutations. Risk factor analysis and implications for genetic testing. JAMA. 1997;278:1242-50.
• Couch FJ, DeShano ML, Blackwood MA, Calzone K, Stopfer J, Campeau L, et al. BRCA1 mutations in women attending clinics that evaluate the risk of breast cancer. N Engl J Med. 1997;336:1409-15.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Based on the data from Milne, hormonal contraception does not impose additional risks for breast cancer among young women who are BRCA positive.
• Therefore, contraceptive options for Jessica are similar to those for other young women.

• Jessica’s lifetime risk because of her BRCA mutation is high, BUT use of birth control pills will not increase her risk.
• Because she is known to be BRCA positive, the most important message for her is to ensure that she gets regular screening for breast cancer.
• Unfortunately, there are no current recommendations for screening in BRCA-positive women; previous guidelines were developed in the 1990s and were based on clinical experience rather than scientific data.

• Milne RL, Knight JA, John EM, Dite GS, Balbuena R, Ziogas A, et al. Oral contraceptive use and risk of early-onset breast cancer in carriers and noncarriers of BRCA1 and BRCA2 mutations. Cancer Epidemiol Biomarkers Prev. 2005;14(2):350-6.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Ask about family history.
• Provide information on use of COCs in women who are known to have a BRCA mutation.
• Ensure that she understands the importance of continued breast cancer screening.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Myths and misperceptions about risks associated with hormonal contraceptives can lead women to restrict their contraceptive choices without cause.
• Given that a woman's contraceptive needs are likely to vary over time, any actual or perceived restriction in choice of method can have unfortunate and unnecessary health and lifestyle consequences.
• Providing women with specific risk information that is placed in context may help them better understand the risks associated with hormonal contraceptives and allow them to make truly informed health decisions. 
• Discussing a reproductive health plan encourages a holistic approach to contraceptive choice and helps women make contraceptive decisions based on their needs, desire for future pregnancies, and any health issues.

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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.

• Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception.


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Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.



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• Clinical Advisory Committee for A Case-Based Approach to Addressing Hormonal Contraception.


Disclosure Text


---
Original content for this slide submitted by Clinical Advisory Committee for A Case-Based
Approach to Addressing Hormonal Contraception in May 2008. Original funding received by
Ortho Women’s Health and Urology through an independent educational grant. This slide is
available at www.arhp.org/core.



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