Slide 1
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Talking Points
This presentation may include
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This presentation may include information that is not on FDA-required product labels.
- NOTE TO SPEAKER: Please disclose any financial relationship(s) you have with industry.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. 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: 4/3/2013
Notes Talking Points
- This presentation has been peer reviewed. Faculty members and their disclosures are listed here.
- Committee members:
Grace Shih, MD, MAS
Laneta J. Dorflinger, PhD
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 3
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Talking Points
Explain the need for new
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Explain the need for new contraceptive methods in the United States to improve reproductive health and prevent unintended pregnancy.
- Examine contraceptive technologies in development that will offer new options for patients in the United States.
- Describe how new methods will meet patient needs to reduce unintended pregnancy in the United States.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 4
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Talking Points
This slide shows figures for
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This slide shows figures for 2006, the most recent year for which data are available. The numbers come from the 2006-2010 National Survey of Family Growth, a series of nationally representative surveys that collect detailed reproductive information from women of reproductive age. These surveys are conducted every few years by the National Center for Health Statistics of the Centers for Disease Control and Prevention (CDC).
- Unintended pregnancy continues to be a major public health issue in the United States (US).
- Nearly half (49%) of pregnancies in the US in 2006 were unintended, up slightly from 2001 (48%).
- Approximately 50% of all unintended pregnancies occurred in the 11% of women who were not using contraception.
- Of the total 6.7 million pregnancies in the US in 2006,
- 4.3 million resulted in a live birth
- 1.4 million ended in abortions
- 1.1 million ended in fetal losses
- Of the 3.2 million (49%) unintended pregnancies in 2006,
- 1.6 million resulted in live births
- 1.4 million ended in abortions
- 0.2 million ended in fetal losses
- These unintended pregnancies accounted for 23% of births, 21% of abortions, and 5% fetal losses.
- About half (48%) of the women who had an unplanned birth had been using a contraceptive method during the month they became pregnant, as had about 60% of those who had abortions.
- Of the 3.5 million (51%) intended pregnancies,
- 2.6 million resulted in live births
- 0.9 million resulted in miscarriages
- The overall pregnancy rate for women aged 15-44 was 108 per 1,000 women in 2006, with an unintended pregnancy rate of 52 per 1,000 women.
- Disparities continue across subgroups for unintended pregnancy rates. The highest pregnancy rates occurred among women aged 20-24, those who are socioeconomically disadvantaged, cohabiting women, and racial/ethnic minority groups, particularly black women. The rate for poor women was 5 times that of women in the highest income level.
- The survey concluded that about half of unintended pregnancies annually are among women who are not using any contraception. However, half are among women who say they had been using contraception during the month they conceived.
- Therefore, it is important to improve correct and consistent use of user-dependent methods and to encourage more use of longer-acting, user-independent methods. (Finer et al. Fertil Steril. 2012)
References
- Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011; 84(5):478-85.
- Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the US, 2007-2009. Fertil Steril. 16 July 2012. doi:10.1016/j.fertnstert.2012.06.027.
- Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38:90-6.
- Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998;30(1):24-9, 46.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 5
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Talking Points
This chart shows the methods
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This chart shows the methods chosen by contraceptive users aged 15-44 years in the US.
- The data are based on self-reported contraceptive practices for the years 2006-2008, from the 2006-2010 National Survey of Family Growth.
- About 62% of all women of reproductive age reported that they were using some form of contraception at the time of the survey, meaning that approximately 38% were not.
- Almost 90% of women at risk of an unintended pregnancy reported using a form of contraception.
- The most frequently used methods included female and male sterilization, oral contraceptive pills, and male condoms.
- Female sterilization was used by 27.1%
- Male sterilization used by 9.9%
- Notably, about one-third of women used oral contraceptives, which must be taken daily.
- More effective methods such as the IUD were used less often—although overall use has increased in recent years, largely due to LNG IUS.
- IUD was used by 5.5%. NOTE: A more recent 2009 analysis (Finer et al.) showed IUD use has made further gains, increasing to 7.7% of current contraceptive users.
- Implants were used by 0.8%
- Approximately 3.5% of women were using the vaginal ring, implant, and contraceptive patch, reversible but effective methods of birth control.
- Patch or implant were used by 1.1%
- Ring was used by 2.4%
- Approximately 3.2% were using the 3-month injectable.
- More than 20% of reported using a contraceptive method considered to be less effective, such as the condom, withdrawal, or other non-hormonal methods such as the sponge, cervical cap, diaphragm, female condom, spermicides, and periodic abstinence.
- On a continuum, method effectiveness generally increases from right to left (on this slide). OCs, which must be taken daily, have a high rate of imperfect use as do injections, patch, and ring, which can lead to method failure.
- Reducing unintended pregnancy means encouraging women to use methods consistently and correctly, as we will see in later slides.
References
- Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. National Center for Health Statistics. Vital Health Stat. 2010;23(29). Available at www.cdc.gov/NCHS/data/series/sr_23/sr23_029.pdf. Accessed 5 July 2012.
- Guttmacher Institute. Contraceptive use in the United States: fact sheet. July 2012.
- Finer et al. Fertility and Sterility . 2012; 98:893-7.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 6
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Talking Points
In this slide, effectiveness
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- In this slide, effectiveness rates for contraceptive methods are expressed in several different ways.
- Effectiveness rates are sometimes expressed as success rates, or the percentage of women who avoid pregnancy during the first year they use that method.
- Effectiveness rates also are sometimes expressed as failure rates, or the percentage of women who are expected to become pregnant within the first year of using the method.
- Effectiveness rates are usually expressed as both perfect use (correct and consistent use of the method with every act of intercourse) and typical use (actual use, including occasional inconsistent or incorrect use).
- The rates in this chart represent typical-use failure rates. This slide presents a comparison in pictorial form of the typical-use effectiveness of contraceptive methods, which patients may find useful.
- This chart has been adapted from the World Health Organization (WHO) chart, Comparing Effectiveness of Family Planning Methods.
- Except where otherwise noted, these rates are based on those reported in the 20th edition of Contraceptive Technology.
- The more effective methods prevent pregnancy more than 99% of the time and include male or female sterilization, implants, and IUDs or intrauterine systems, called IUC for intrauterine contraception on this slide.
- Effective methods include injectables, oral contraceptives (pills), the patch, the ring, and the diaphragm, which prevent pregnancy more than 88% of the time.
- Recent clinical trials have shown that the typical-use effectiveness of the diaphragm falls within this category.
- Less effective methods include the male and female condoms, sponge, withdrawal, spermicides, the cervical cap, and fertility awareness methods (e.g., Standard Days method, TwoDay method, ovulation method, and symptothermal method), which are likely to prevent pregnancy about 75% of the time under typical use.
References
- Trussell J, Guthrie KA. Choosing a contraceptive: efficacy, safety, and personal considerations. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology: 20th Revised Edition. New York: Ardent Media; 2011. pp. 45-74.
- Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th revised ed. New York: Ardent Media; 2011.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 7
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Talking Points
The number of women of
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- The number of women of reproductive age who will need contraception will continue to grow.
- By 2029, there could be more than 70 million women ages 15-44.
- Ensuring not only that women now, but in the expanding population of the future, have access to methods that will meet their varying needs over their reproductive lives is essential and will be a substantial challenge.
References
- McFarlane K. New Contraceptives in Development: detailed information on AG200-15, a low-dose contraceptive patch. SmartPharma LLC slide set.
- US Census Bureau, National projections released 2008 based on 2000 Census (Internet release May 2009)
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 8
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Talking Points
4.5 million women in the US
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- 4.5 million women in the US have an unmet need for contraception.
- Despite the fact that almost 90% of women at risk of pregnancy are using a contraceptive method, many women are using methods incorrectly or inconsistently and choose to switch frequently.
- In addition, women who initiate contraception often discontinue within 1 year.
- There is a large need for effective contraception to prevent unintended pregnancy.
- Rates of unintended pregnancy among women ages 15-44 rose from 7.5% in 1995 to 10.6% in 2006-2008.
- New, highly effective, and easy-to-use methods could reduce obstacles to initiation and continued use of effective contraception.
- Lower-cost methods with fewer side effects
- Easier methods that are more appealing to use
- A wide variety of contraceptive methods are needed to meet the needs of the modern world.
- Women’s contraceptive needs change as they enter different phases of reproductive life.
- Effective methods are needed for women who have serious chronic diseases that make hormonal methods an unacceptable option.
- Education on new and currently available methods for providers and for patients is essential to this process.
References
- Schwartz J, Gabelnick HL. Contraceptive research and development. In: Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media; 201.
- Brody J. Switching contraceptives effectively. The New York Times. September 2012. Available at: http://well.blogs.nytimes.com/2012/09/17/switching-contraceptives-effectively/
- Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011; 84(5):478-85.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 9
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Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates 2.1 million women in the US use IUC devices. IUD use has risen consistently since 2002, reflecting the popularity of this method. The levonorgestrel intrauterine system (LNG IUS; Mirena®) is currently the most popular among US women.
- Candidates include all women of reproductive age who are seeking a long-term, convenient, highly effective contraceptive method.
- IUDs generally have an expensive upfront cost but, because of their longevity, are cost-effective over time.
- New hormonal IUCs give the hope of
- providing a lower-cost option,
- reducing the discomfort and cramping that some women experience with the current option, and
- providing a hormonal IUC option for women whose uterine depths are too small to accommodate the LNG 52 IUS (Mirena®).
- LNG 13.5 IUS (SkylaTM; had been referred to in some literature as “LCS 12”)
- What is it?
- Bayer developed this new LNG IUS to be smaller and lower-dose than Mirena®, with the goal of greater acceptability among younger, nulliparous women.
- Indicated for prevention of pregnancy for up to 3 years.
- What’s different?
- LNG 13.5 IUS contains 13.5 milligrams (mg) of LNG and releases approximately 14 micrograms (mcg) of LNG per day after 24 days, and declines to 5 mcg/day after 3 years.
- In comparison, the LNG 52 IUS (Mirena®) contains 52 mg of LNG, released at a rate of about 20 mcg/day, decreasing to half that amount over its recommended life.
- LNG 13.5 IUS (SkylaTM) is now the smallest IUC available; it has the smallest frame and smallest insertion tubes, making insertion potentially better for nulliparous women.
- In phase 2 and phase 3 studies, LNG 13.5 IUS (SkylaTM) was compared with LNG 52 IUS (Mirena®) over 3 years of follow-up.
- Overall, LNG 13.5 IUS (SkylaTM) provided effective contraception, acceptable bleeding patterns, and was well tolerated compared with LNG 52 IUS (Mirena®); easy placement and low pain was reported.
- Is it available in the US? LNG 13.5 IUS (SkylaTM) is FDA approved and available in the US as of April 2013.
References
- Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3.Epub 2012 Jan 4. Available at: www.ncbi.nlm.nih.gov/pubmed/22222193?dopt=Abstract. Accessed August 2012.
- Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: 20th revised ed. New York, NY: Ardent Media, 2011.
- FDA. Trends in NDA and BLA Submissions and Approval Times. Available at: www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm209349.htm. Accessed August 2012.
- Finer et al. Fertility and Sterility (2012) 98:893-897. Available at www.fertstert.org/article/S0015-0282%2812%2900680-2/abstract.
- Bayer. 2011 Annual Report: Available at www.annualreport2011.bayer.com/en/research-and-development.aspx.
- Bayer. Highlights of Prescribing Information. Available at http://labeling.bayerhealthcare.com/html/products/pi/Skyla_PI.pdf. Accessed March 2013.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 10
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Talking Points
Data are not published but
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Data are not published but provided from the lay press.
- Results of the phase 3 study were announced in October 2012 at the American Society for Reproductive Medicine 68th Annual Meeting:
- This global, randomized, open-label study included 2,884 women ages 18-35 years with regular menstrual cycles (21-35 days) requesting contraception.
- Participants were randomly assigned to LNG 13.5 IUC (SkylaTM) or another IUC in development, LNG 19.5.
- 39% of participants had never had a child; the remainder had at least one child.
- The Pearl Index (PI)—number of pregnancies per 100 woman-years—was the primary efficacy endpoint and is based on pregnancies that occurred after the start of treatment and within 7 days after IUD removal or expulsion.
References
- Phase 3 study evaluates two investigational hormone-releasing IUDs for prevention of pregnancy for up to three years. PR Newswire. October 2012. Available at: www.prnewswire.com/news-releases/phase-3-study-evaluates-two-investigational-hormone-releasing-iuds-for-prevention-of-pregnancy-for-up-to-three-years-175321361.html. Accessed October 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 11
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Talking Points
Anna’s profile:
Anna is a
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Anna’s profile:
- Anna is a 22-year-old, nulliparous woman interested in changing her birth control method.
- She weighs 100 lbs and is 5’ 2’’.
- She used to take birth control pills but was not good at taking them daily.
- She is interested in the IUD but is scared of the insertion procedure.
- Question: Why might the new LNG 13.5 IUS (SkylaTM) be a good choice for Anna?
- In trials, study participants reported low pain with LNG 13.5 IUS (SkylaTM) during placement.
- Compared with LNG 52 IUS (Mirena®), insertion of the LNG 13.5 IUS (SkylaTM) may provide less discomfort and cramping.
- The LNG 13.5 IUS (SkylaTM) can last 3 years.
- All of these.
- None of these.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 12
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Talking Points
Anna’s profile:
Anna is a
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Anna’s profile:
- Anna is a 22-year-old, nulliparous woman interested in changing her birth control method.
- She weighs 100 lbs and is 5’ 2’’.
- She used to take birth control pills but was not good at taking them daily.
- She is interested in the IUD but is scared of the insertion procedure.
- Question: Why might the new LNG 13.5 IUS (SkylaTM) be a good choice for Anna?
- In trials, study participants reported low pain with LNG 13.5 IUS (SkylaTM) during placement; data was based on patient self-report on a questionnaire using a Likert-like scale.
- Compared with LNG 52 IUS (Mirena®), insertion of the LNG 13.5 IUS (SkylaTM) may provide less discomfort and cramping; data based on small number of subjects in a phase II study.
- The LNG 13.5 IUS (SkylaTM) can last 3 years.
- All of these.
- None of these.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 13
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- The primary goal of contraceptive drug development is to expand the number of safe and effective options available.
- This slide illustrates methods likely to be available in the next 2 years in the United States and those that should enter the US market sometime after 2014.
- The methods likely to be available in 2013-2014 are all hormonal methods that are for women:
- Medroxyprogesterone acetate (MPA) 25 mg and estradiol cypionate 5 mg monthly injectable
- Levonorgestrel (LNG)/ethinyl estradiol (EE) transdermal patch
- Methods likely to be available after 2014 include:
- Nestorone/EE contraceptive vaginal ring
- Gestodene/EE transdermal patch
- Levonorgestrel (LNG) 19.5 IUS
- Levonorgestrel (LNG) 20 IUS
- SILCS diaphragm
- Female condom, developed by PATH (Program for Appropriate Technology in Health)
- Many new pills are in clinical trials, and many more have entered the market in the last few years. At the time of the last National Survey of Family Growth, 88 brands of pills were available in the United States. This presentation will provide a few examples of some new pills that may be entering the market (not a comprehensive list).
Reference
- Hall KS and Trussell J. Types of combined oral contraceptives used by US women. Contraception. 2012;86:659-65.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 14
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Talking Points
This device is similar to the
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This device is similar to the LNG 13.5 but contains 19.5 micrograms of levonorgestrel (LNG).
- LNG 19.5 is in phase 3 development, and it is unclear when an application may be submitted in the US.
- LNG 19.5 may have potential to last 5 years.
- LNG 19.5 had been referred to as LCS 16 in previous literature.
References
- Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012;97(3):616-22.e1-3.Epub 2012 Jan 4. Available at: www.ncbi.nlm.nih.gov/pubmed/22222193?dopt=Abstract. Accessed August 2012.
- Hatcher RA, Trussell J, Nelson AL, et al., eds. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media, 2011.
- FDA. Trends in NDA and BLA Submissions and Approval Times. Available at: www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm209349.htm. Accessed August 2012
- Finer et al. Fertil Steril. 2012;98:893-7. Available at: http://www.fertstert.org/article/S0015-0282%2812%2900680-2/abstract.
- Bayer 2011 Annual Report. Available at: www.annualreport2011.bayer.com/en/research-and-development.aspx.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 15
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Talking Points
New Monthly Injectable
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Notes Talking Points
- New Monthly Injectable (Cyclofem)
- What is it?
- A monthly injectable containing estrogen and a progestin—25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate.
- Cyclofem has been used in a number of developing countries since its introduction in the early 1990s, particularly in Indonesia and Latin America.
- It has the same formulation as injectable previously marketed in the U.S. (Lunelle®).
- The progestin, medroxyprogesterone acetate, is the same one used in the 3-month injectable.
- It’s licensed to the Concept Foundation under its collaborative agreement with WHO. Concept Foundation licensed rights to Sun Pharmaceutical Industries of Mumbai, India.
- What’s different?
- The existing DMPA injectable (Depo-Provera®) is given once every 3 months; this new method in development is a monthly injectable.
- The new method in development results in fewer menstrual irregularities and fewer reports of amenorrhea. Studies show high efficacy and more regular bleeding patterns than with progestin-only injectables, no effect on blood pressure, and more rapid return to fertility.
- The new method in development provides a safe and effective choice to younger women at the beginning of their contraceptive life cycle.
- When will it be available in the US?
- A pharmacokinetic and pharmacodynamic study in women has been conducted by Conrad. This study is the first step in obtaining FDA approval.
- The Concept Foundation is collaborating with Sun Pharmaceutical Industries to obtain FDA approval. FDA approval would also allow reintroduction to the US market. The timing of FDA approval and reintroduction is unclear.
- Hatcher RA, Trussell J, Nelson AL, et al., editors. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media, 2011.
- Estrogen/progestin hormonal injections. Center for Young Women’s Health Web site. Available at: www.youngwomenshealth.org/femalehormone3.html. Accessed September 2012.
- Conception Foundation. Access to hormonal contraception. Available at: www.conceptfoundation.org/hormonal-contraception.php. Accessed September 2012 .
- CONRAD. Research grid. Available at: www.conrad.org/contraception-trials.html. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 16
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Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates that about 400,000 women in the United States use the norelgestromin/ethinyl estadiol transdermal patch (Ortho Evra®).
- Two new patches are under development, including the EE + LNG patch described above, which has been known to some as “Twirla™”.
- Agile also received a notice of allowance for the trademark Twirla™, and conditional acceptance from the FDA to use the proprietary name “Twirla” for its AG200-15 contraceptive patch, pending final agency review prior to NDA approval.
- New EE + LNG low-dose patch (Twirla™)
- What is it?
- 26 cm2 weekly transdermal contraceptive patch that releases 100 µ levonorgestrel and 30 µ ethinyl estradiol daily (both of which have a well-established history of efficacy and safety in combination contraceptives)
- Applied once weekly for 3 weeks followed by 1 patch-free week
- Why use it? What’s different?
- This patch is soft and flexible with a cloth-like feel
- The transdermal drug-delivery system has an inner, active matrix adhesive system that delivers both EE and LNG through the skin. The outer, peripheral adhesive system is responsible for patch adherence, stability, and patient comfort.
- It’s designed to provide excellent adhesion, comfort, and appearance—to minimize seepage of adhesive around the edge of the patch to decrease chance of a black ring of residue on the skin.
- Data from a phase 3 study showed that it delivers an EE dose comparable to an oral dose of 30 µ/day.
- It can be applied to abdomen, buttocks, or upper torso.
- When will it be available in the US?
- A New Drug Application (NDA) has been submitted to FDA based on phase 3 clinical trial results demonstrating that it delivers an EE dose comparable to an oral dose of 30 µ/day.
- As with oral contraceptive pills, women may find that different doses and type of hormones in the new patches work better (or less well) for them.
Reference
- Agile Therapeutics. About AG200-15. Available at: www.agiletherapeutics.com/AG200-15.html. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 17
Slide 17 of 30
Talking Points
This slide shows the adverse
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This slide shows the adverse event profile reported in the phase 3 clinical trial of the new low-dose patch. The data are compared with historical data on the existing patch.
- The new low-dose patch shows low levels of typical hormone-related side effects, especially compared with the approved patch.
- Rates of hormone-related adverse events are within the range reported for low-dose combination oral contraceptives.
References
- Kaunitz AM, Mishell DR, Foegh M. Comparative Phase 3 Study of AG200-15, a Low-Dose Estrogen and Levonorgestrel Contraceptive Patch. Poster CL12 presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting, San Diego, May 2012.
- Stanczyk FZ, Archer DF, Foegh M. The Pharmacokinetic Profile of AG200-15, a Low-dose Contraceptive Patch, Is Equivalent at Three Anatomical Sites. Poster CL15 presented at the ACOG Annual Clinical Meeting, San Diego, May 2012.
- Archer DF, Stanczyk FZ, Foegh M. Adhesiveness and Pharmacokinetics of a Low-Dose Contraceptive Patch Under Daily External Stressors – Heat, Humidity, Cold Water, and Exercise. Poster CL16 presented at the ACOG Annual Clinical Meeting, San Diego, May 2012.
- Archer DF, Stanczyk FZ, Rubin A, Foegh M. Pharmacokinetics and adhesion of the Agile transdermal contraceptive patch (AG200-15) during daily exposure to external conditions of heat, humidity, and exercise. Contraception. 2013 Feb;87(2):212-9. doi: 10.1016/j.contraception.2012.10.009. Epub 2012 Nov 15.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 18
Slide 18 of 30
Talking Points
This figure illustrates the
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- This figure illustrates the relative pharmacokinetic (PK) profiles of the new low-dose patch compared with a daily 35 mcg EE oral contraceptive (OC) and the norelgestromin/ethinyl estadiol transdermal patch (Ortho Evra®), which is also labeled as releasing 35 mcg EE per day.
- The average steady-state levels of EE are lower than reported for the current patch.
- It is important to note the FDA added a warning label to the patch about deep vein thrombosis (DVT). This PK profile suggests that lower estrogen levels with the new patch may lead to the better side effect profile seen on the previous slide, as well as a lower risk of venous thromboembolism.
- Phase 3 studies evaluating efficacy and safety are complete; limited data have been published.
References
- Archer DF, Stanczyk FZ, Rubin A, et al. Serum Ethinyl Estradiol Levels With a Low-Dose Combination Transdermal Contraceptive (AG200-15) Compared with a Low-Dose Combination Oral Contraceptive. Poster presentation #0068 at Reproductive Health 2011, Association of Reproductive Health Professionals (ARHP), Las Vegas, September 2011.
- Stanczyk FZ, Archer DF, Foegh M. The Pharmacokinetic Profile of AG200-15, a Low-dose Contraceptive Patch, Is Equivalent at Three Anatomical Sites. Poster CL15 presented at the ACOG Annual Clinical Meeting, San Diego, May 2012.
- Archer DF, Stanczyk FZ, Foegh M. Adhesiveness and Pharmacokinetics of a Low-Dose Contraceptive Patch Under Daily External Stressors – Heat, Humidity, Cold Water, and Exercise. Poster CL16 presented at the ACOG Annual Clinical Meeting, Can Diego, May 2012.
- Archer DF, Stanczyk FZ, Rubin A, Foegh M. Pharmacokinetics and adhesion of the Agile transdermal contraceptive patch (AG200-15) during daily exposure to external conditions of heat, humidity, and exercise. Contraception. 2012 Nov 15. pii: S0010-7824(12)00898-0. doi: 10.1016/j.contraception.2012.10.009. [Epub ahead of print]
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 19
Slide 19 of 30
Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates that about 400,000 women in the United States use the norelgestromin/ethinyl estadiol transdermal patch (Ortho Evra®).
- Two new patches are in development. The potential advantages of one over another will not be known until head-to-head clinical trial studies are conducted. As with oral contraceptive pills, women may find that different doses and type of hormones in the new patches work better (or less well) for them.
- Combined hormonal contraception patch:
- According to the clinicaltrials.gov database, this patch is being studied, but little is known about the device.
- What is it?
- The transdermal patch contains 0.55 mg ethinyl estradiol and 2.1 mg gestodene.
- It’s transparent and is intended to be the smallest, lowest-dose contraceptive patch on the market.
- This patch is in phase 3 clinical trial.
- Why use it? What’s different?
- A study comparing the norelgestromin/ethinyl estadiol transdermal patch and this patch is examining patterns of bleeding, effectiveness in preventing pregnancy, safety, and acceptability.
References
- Bayer HealthCare. Birth Control Patch Study. Available at: http://healthcare.bayer.com/scripts/pages/en/research_development/clinical_trials/trial_finder/trialfinder_detail.php?trialid=13082&search=BAY86-5016&product=&overall_status=&country=&phase=&condition=&results=0&trials=&btnSubmit=submit&num=10&show=1. Accessed September 2012.
- Bayer 2011 Annual Report. Available at: www.annualreport2011.bayer.com/en/research-and-development.aspx.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 20
Slide 20 of 30
Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Jennifer’s profile:
- 23-year-old Jennifer used to use the patch.
- She stopped because after exercise, she would get a sticky ring around the patch.
- Her breasts also felt tender when she used the patch.
- However, she liked the weekly formulation and the idea of birth control she could see and feel.
- Question: Why might EE + LNG 15 mcg patch be a good choice for Jennifer?
- It has half the progestin exposure of the currently available patch.
- It’s more reliable than a combined oral contraceptive pill.
- It has less adhesive seepage than the current patch.
- It’s more effective than the current patch.
- Answer: C – It has less adhesive seepage than current patch
- A – The progestins used in the EE + LNG 15 mcg patch and the currently available patch are different, so one cannot directly compare the doses.
- B – The new patch is comparable to a combined oral pill.
- D – Comparative effectiveness isn’t known yet, but they should have similar efficacy.
- - -
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 21
Slide 21 of 30
Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Jennifer’s profile:
- 23-year-old Jennifer used to use the patch.
- She stopped because after exercise, she would get a sticky ring around the patch.
- Her breasts also felt tender when she used the patch.
- However, she liked the weekly formulation and the idea of birth control she could see and feel.
- Question: Why might EE + LNG 15 mcg patch be a good choice for Jennifer?
- It has half the progestin exposure of the currently available patch.
- It’s more reliable than a combined oral contraceptive pill.
- It has less adhesive seepage than the current patch.
- It’s more effective than the current patch.
- Answer: C – It has less adhesive seepage than current patch
- A – The progestins used in the EE + LNG 15 mcg patch and the currently available patch are different, so one cannot directly compare the doses.
- B – The new patch is comparable to a combined oral pill.
- D – Comparative effectiveness isn’t known yet, but they should have similar efficacy.
- - -
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 22
Slide 22 of 30
Talking Points
LNG 20
What is it?
It’s a
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- LNG 20
- What is it?
- It’s a device designed to be comparable to the currently-available LNG IUS, Mirena® (same daily dose: 20 mcg).
- A phase 3 trial is in progress of a levonorgestrel-releasing IUS, made by Uteron Pharma Operations (UPO) from Liege, Belgium, for long-term reversible contraception.
- This is a randomized, multi-center, open-label study comparing the LNG 20 with LNG IUS as a contraceptive option for nulliparous and parous females who want a long-term reversible method.
- The primary endpoint is pregnancy rate over 5 years. An estimated 2,080 women will be enrolled and randomly assigned to one of the two devices.
- Secondary outcome measures include adverse events over the study’s 5-year duration, levonorgestrel levels during the study, and fertility rates 1 year after removal of the IUS.
- What’s different?
- Plans are to market this device at a lower cost than the current LNG IUS.
- The aim is to extend the use from 5 to 7 years; the LNG IUS is labeled for 5 years.
- When will it be available in the US?
- The study is estimated to be completed by December 2018. Final data collection for the primary outcome measure is estimated to be December 2017.
- This product is not likely to be available before 2020—2018 if they go for a 3-year label rather than a 5-year label.
References
- Medicines360. A Study of Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception. Available at: www.clinicaltrials.gov/ct2/show/NCT00995150?term=medicines360&rank=1. Accessed August 2012.
- Hatcher RA, Trussell J, Nelson AL, et al., editors. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media, 2011.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 23
Slide 23 of 30
Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates that about 900,000 women in the United States use the etonogestrel/ethinyl estradiol vaginal ring (NuvaRing®).
- Nestorone/Ethinyl Estradiol (NES/EE) 1-year contraceptive vaginal ring (CVR)
- What is it?
- Effective, convenient, easily-used vaginal ring which releases 150 mcg Nestorone and 15 mcg ethinyl estradiol/day.
- The ring is left in place for 3-weeks and removed for one week. Each ring is good for up to 13 cycles (one full year).
- Nestorone is a progestin that will be new to the US market. NES is a potent 19-norprogesterone derivative with no androgenic or estrogenic action. It is inactive orally but highly effective in blocking ovulation when given by non-oral routes.
- The soft and flexible ring is roughly 2-1/4 inches in diameter
- What’s different?
- Unlike the etonogestrel/ethinyl estradiol CVR, this ring will last for 1 year. It doesn’t require daily action or any action related to coitus.
- It doesn’t require refrigeration. It’s stored in a case when it’s not in use.
- It’s intended to be easily inserted by the woman, which eliminates the need for repeated visits to a doctor or pharmacy.
- Nestorone lacks androgenic effect; weight/lipids are favorable.
- Phase 3 clinical trials found a high level of user satisfaction.
- Phase 3 results suggest the ring is as effective as oral contraceptives in preventing pregnancy when used as directed.
- When will it be available in the US?
- In 2010, the Population Council announced an exclusive licensing agreement with Watson Pharmaceuticals, Inc., to commercialize the NES/EE CVR in the United States, Canada, and Mexico.
- The Population Council plans to file an NDA seeking FDA approval sometime in the next 2 years.
- It should be available ~2016 in the US.
References
- Merkatz RB. Nestorone/Ethinyl Estradiol Contraceptive Vaginal Ring. International Conference on Family Planning: Research and Best Practices, Uganda. November 15-18, 2009. Available at: www.fpconference2009.org/media//DIR_169701/15f1ae857ca97193ffff833fffffd524.pdf. Accessed September 2012.
- Population Council. One-year Combination Vaginal Ring, Phase 3 Study. Available at: www.popcouncil.org/projects/115_OneYearCombVagRing.asp. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 24
Slide 24 of 30
Talking Points
Most participants in the
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- Most participants in the phase 3 clinical trial
- were satisfied with the nesterone/EE 1-year CVR
- found the new CVR easy to use
- would pay for it if it were available
- would recommend it to friends
- preferred it to other methods they have used
References
- Merkatz R. Nestorone/Ethinyl Estradiol Contraceptive Vaginal Ring. November 15-18, 2009. International Conference on Family Planning: Research and Best Practices, Uganda.
- Population Council. One-year Combination Vaginal Ring, Phase 3 Study. Available from: www.populationcouncil.org/projects/115_OneYearCombVagRing.asp. Accessed October 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 25
Slide 25 of 30
Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates that 10.7 million women in the United States use oral contraceptives (OCs). Data from the most recent NSFG indicate 88 brands of pills were available in the US.
- Candidates for pills are women who want to regulate menses and will consistently use a daily method.
- A high number of unintended pregnancies are caused by inconsistent use, misuse, or discontinuation of OCs. By the 3rd month of use, the typical user misses 3 or more pills each cycle.
- 2010 marked the 50th anniversary of the availability of combined OCs in the US.
- Many new pills are in clinical trials, and many more have entered the market in the last few years that are different from those that have been around for 20-30 years.
- Goals for new pills should be fewer side effects, enhanced safety, and greater forgiveness when pills are missed. Examples of recent advances include a reduced pill-free interval, addition of folic acid, and use of estradiol valerate or 17ß-estradiol instead of EE.
- Here are a few examples of what may be entering the market (this is not a comprehensive list, and these data have not been published).
- A 90-day ascending dose regimen OC of LNG 0.15mg/EE 20ug x42 days, 25ug x 21 days, and 30ug x 21 days, and EE 20 µg x 7 days.
Why use it?/What’s different?
- Designed to have less disruptive, unscheduled bleeding
When available in the US?
- NDA filed August 2012
- Company hopes to have approval by late 2013
- Bayer
What is it?
- OC extended regimen of drosperinone 3 mg/ EE 20 mcg
Why use it? What’s different?
- Extended regimen of drospirenone plus 20 mcg EE with a flexible schedule that would allow women a flexible regimen in managing bleeding.
- It is being marketed in some other countries, including Australia.
When will it be available in the US?
- It is under FDA review in the US, and a decision is expected in April 2013.
- Indication being sought to manage bleeding.
- Merck
What is it?
- OC containing nomegestrol acetate, a highly selective, progesterone-derived progestin and 17beta- estradiol (E2). It’s used in a 24/4 cycle (24 active pills and 4 placebo).
Why use it? What’s different?
- A natural estradiol that may be safer than EE (data remain to be gathered).
When will it be available in the US?
- Merck received a non-approvable Complete Response Letter (CRL) from FDA on November 4, 2011, and needs to provide additional information to the agency before approval.
- BioSante and Pantarhei Bioscience
What is it?
- OC containing estrogen, progestin, and androgen (androgen-restored contraception; ARC)
Why use it? What’s different?
- Androgen loss occurs with current oral contraceptives, which potentially causes reduced arousal, orgasms, and pleasure in OC users.
- Small studies have shown this OC to increase frequency of sexual activity, arousal, responsiveness to partner, genital sensations, and vaginal lubrication.
- No significant androgenic effects were noted.
When will it be available in the US?
- A phase 3 study in female sexual dysfunction failed in December 2011; additional data are needed before it will be available in the US.
References
- McFarlane K. New Contraceptives in Development: Detailed information on AG200-15, a low-dose contraceptive patch. SmartPharma LLC slide set.
- Teva receives FDA acceptance of its new drug application for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the prevention of pregnancy. Business Wire. Available at: www.businesswire.com/news/home/20120813005849/en. Accessed September 2012.
- BioSante Pharmaceuticals. The Pill-Plus. Available at: www.biosantepharma.com/The-Pill-Plus.php. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 26
Slide 26 of 30
Talking Points
In the 1960s, more than 10%
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- In the 1960s, more than 10% of married women in the US used a diaphragm for birth control. Today, fewer than 1% do.
- Diaphragms offer reusable, inexpensive protection from pregnancy and some STIs.
- There is interest in bringing the diaphragm back. Women want it to be easier to get and use, and they want it to offer protection against more than just pregnancy.
- SILCS diaphragm
- What is it?
- The SILCS diaphragm (“not your mother’s diaphragm”) is a single-size device that is designed to work with an individual woman’s anatomy. It is pushed into place, covers the cervix, and when the cervix moves, the SILCS moves with it.
- The SILCS spring has bending characteristics that allow a soft folding force for ease of insertion and removal.
- The device was developed by PATH and SILCS, Inc. USAID supported product development and clinical trials through PATH and CONRAD, respectively.
- Why use it? What’s different?
- It’s a non-hormonal method, easy to stop and start, and under the woman’s control.
- It’s distinguished from the standard diaphragm with dimples on the side and a wedged fit.
- The “one-size-fits-most” design avoids the need for many sizes and a pelvic exam for a correct fit and eliminates the need to overstock multiple sizes.
- It’s easy to use and comfortable (made of silicone instead of latex).
- When bent for insertion, the leading edge provides stability and helps guide the SILCS diaphragm deep into the vagina as the woman pushes on the posterior edge.
- The posterior edge has a fingertip dome to make it easier to remove.
- The cervical cup is large enough to accommodate most cervices and yet pliable enough to collapse when there is unused space.
- Grip dimples help orient the woman’s fingers and provide a tactile cue for where to hold and squeeze the rim.
- CONRAD (with USAID funding) has a new study looking at the diaphragm as a delivery method for microbicide gel to protect from HIV and other STIs and unintended pregnancy (tenofovir gel with SILCS studies in sub-Saharan Africa).
- 2011 study results of 450 US couples indicate the effectiveness rate of SILCS is similar to that of traditional diaphragms.
- It could be made available over the counter if approved by appropriate regulatory bodies.
- When will it be available in the US?
- The device is not yet approved, but developers are working toward approval.
- Women are evaluating the new device for comfort and ease of use in studies under way in the Dominican Republic, South Africa, Thailand, and the US.
- PATH licensed the design to Kessel of Frankfurt, Germany, in late 2010. Kessel is working toward introducing the device in select European countries, where women can already buy diaphragms over the counter, under the brand name Caya® countoured diaphragm in 4Q 2012.
- Kessel plans to submit a 510K application to the FDA.
References
- Schwartz J, Gabelnick HL. Contraceptive research and development. In Hatcher RA, Trussell J, Nelson AL, et al., editors. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media, 2011.
- PATH Publications. Technology Update: SILCS Diaphragm. Available at: www.path.org/publications/detail.php?i=1233.
- PATH. Single-sized, easier to use. Available at: www.path.org/projects/silcs.php. Accessed September 2012.
- Bedsider. SILCS: It’s not your mama’s diaphragm (not her spermicide, either). Available at: http://bedsider.org/features/159. Accessed September 2012.
- Contraceptive Technology Update. New data emerges on one-size diaphragm. December 2011. Available at: www.conrad.org/media/news/104_Contraceptive%20Technology%20article%20on%20SILCS.pdf. Accessed September 2012.
- CONRAD. Research Grid. Available at: www.conrad.org/contraception-grid.html. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 27
Slide 27 of 30
Talking Points
A 2012 Guttmacher report
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- A 2012 Guttmacher report indicates EC, female condom, foam, cervical cap, Today’s sponge, suppository or insert, and jelly or cream (without diaphragm) are used by 200,000 million women in the US.
- PATH Women’s Condom
- What is it?
- PATH has a new female condom designed with a dissolving capsule to make insertion easier. The new devise also has a polyurethane condom pouch with foam dots that facilitate gentle adherence to the vaginal walls, and a soft outer ring.
- What’s different?
- It’s easier to handle, insert, use, and remove.
- It’s more comfortable during sex for both partners.
- It does not slip or move around.
- The pouch is collapsed into a thin capsule, which is used to help insert the condom into the vagina.
- It gently adheres to the vaginal wall.
- It’s unlubricated and supplied with a 3-ml water-based lubricant, which is applied to the inside of the pouch after insertion.
- An aluminum foil laminate keeps the condom fresh.
- When will it be available in the US?
- PATH licensed Dahua Medical Apparatus Company of Shanghai, China, to manufacture and distribute the Woman’s Condom in 2008. Dahua received State Food and Drug Administration (SFDA) (2011) and CE Mark (2010) approval, which allows for distribution and marketing in China and Europe. Dahua has submitted a dossier for WHO pre-qualification.
- The product is commercially available in select channels of China (brand name O’Lavie, which means “life” in French).
- CONRAD is collaborating with the California Family Health Council on a study comparing the self-reported clinical failure rates of the Woman’s Condom and the FC2 Female Condom. This study is using vaginal detection of prostate-specific antigen as an indicator of condom failure in an effort to demonstrate that this kind of trial can replace contraceptive efficacy trials for approval of new female condoms.
- In parallel, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Contraceptive Clinical Trials Network is conducting the pivotal phase 3 contraceptive efficacy study required for FDA approval of the Woman’s Condom.
References
- Information about FC2® Female Condom and Its Use. The Female Health Company. Available at www.fc2.us.com/home.html. Accessed on 6 July 2012.
- Schwartz J, Gabelnick HL. Contraceptive research and development. In Hatcher RA, Trussell J, Nelson AL, et al., editors. Contraceptive Technology. 20th Revised Edition. New York: Ardent Media, 2011.
- PATH Publications. Technology Update: Women’s Condom. Available at: www.path.org/publications/detail.php?i=1237. Accessed July 6, 2012.
- CONRAD. Research Grid. Available at: www.conrad.org/contraception-grid.html. Accessed September 2012.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 28
Slide 28 of 30
Talking Points
The wide variety of new
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Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- The wide variety of new options described above will expand choice for American women; however, these options are all largely variations of existing methods.
- Research has documented that existing methods do not meet the needs of all women [23].
- Adding truly innovative methods to the current contraceptive mix should be more than a goal—indeed an expectation—over the next decade.
- Women would benefit from novel drug delivery systems that simplify use, low-cost non-surgical sterilization approaches, highly effective non-hormonal options, and methods that offer additional health benefits beyond contraception, including dual-purpose technologies to prevent pregnancy and STIs (e.g., HIV, HSV, and HPV)[24, 25].
- In addition, reversible methods for men are noticeably absent, despite decades of effort and evidence that male contraception would be acceptable to many men and their partners [26, 27].
- Contraceptive research and development must be infused with the resources and focus that have been applied to other therapeutic areas. Truly innovative contraceptive technologies could offer important advantages, reduce unintended pregnancies, and improve the overall health of women in the United States and elsewhere.
References
- Dorflinger L. New developments in contraception for US women. Contraception. 2013; in press.
- Spieler J. Contraceptive Technologies Offer New Options. USAID Impact Blog. Available at: http://blog.usaid.gov/2011/09/contraceptive-technologies-offer-new-options/. Accessed April 2013.
Disclosure Text
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 29
Slide 29 of 30
Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- ARHP. Method Match. www.arhp.org/methodmatch.
- US Clinical Trials Database. www.clinicaltrials.gov.
- Contraceptive Technology, 20th Revised Edition. www.contraceptivetechnology.com
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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Slide 30
Slide 30 of 30
Source: Association of Reproductive Health Professionals
Peer Review Date: 4/3/2013
Notes Talking Points
- ARHP. Method Match. www.arhp.org/methodmatch.
- US Clinical Trials Database. www.clinicaltrials.gov.
- Contraceptive Technology, 20th Revised Edition. www.contraceptivetechnology.com
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Developments in Contraception in September 2012. This project is funded through educational grants from Agile Therapeutics, Teva Pharmaceuticals, and Bayer HealthCare Pharmaceuticals. Last reviewed/updated in April 2013. This slide is available at www.arhp.org/core.
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