A new type of oral contraceptive pill
Assessing potential demand
Working with Gynuity Health Projects and other partners, PATH is helping assess the potential and value of a contraceptive pill a woman could take only before or after sex, eliminating the need for a method that provides daily contraception. It could become a popular alternative for women who have infrequent sex, want short-term contraception, or are using other methods and want extra, or additional, protection.
Emerging evidence suggests that women may be interested in this kind of method. Studies from multiple countries have documented that some women are already using emergency contraceptive pills or other drugs before or after sex as their regular method of contraception. In addition, about 20 percent of women in sub-Saharan Africa and South and Southeast Asia cite infrequent sex as the reason for an unmet need for family planning. They may be more satisfied with a method that they can use “on demand,” or as needed. There is no contraceptive pill currently marketed for such use.
A pericoital or on-demand oral contraceptive method could provide women with several advantages. The fact that women won’t need to take a daily pill might make it more convenient and easier to use, and it may be more discreet and private than some currently available barrier methods.
Gynuity Health Projects has received support from the Bill & Melinda Gates Foundation to plan for possible Phase 3 clinical trials and other steps in the product development process for this new method. PATH is collaborating with Gynuity (and applying additional support from the William and Flora Hewlett Foundation) to assess the potential demand for a new oral contraceptive product in two settings: Uttar Pradesh, India and Kampala, Uganda. PATH and our partners in each setting will conduct focus group discussions and in-depth interviews with potential end-users (women and men), family planning providers, and key opinion leaders. These discussions will explore the appeal of this new method among various potential market segments, as well as the enabling and inhibiting factors for product supply. Results will be available in summer 2012.
Planning for product introduction
In 2011, PATH held discussions with more than 40 expert family planning stakeholders, including commercial manufacturers of family planning products, to identify critical steps for product development and introduction. The discussions focused on six key domains: product (commercial partnerships and clinical research), regulatory, procurement and distribution, policy and guidelines, demand generation, and education for users and service providers. Discussions were analyzed to develop a critical pathway to illustrate key issues for consideration in the development, introduction, and scale-up of this new health technology. PATH is building on the critical pathway work to develop a potential product introduction strategy with Gynuity under their current project, assuming the method moves forward.
PATH has also coordinated closely with the International Consortium for Emergency Contraception (ICEC) on this effort, as the specific product under most serious consideration for development is currently levonorgestrel (LNG). LNG pills are currently marketed worldwide as emergency contraceptive pills. They are widely available, relatively inexpensive to produce, and have an excellent safety profile. Reviews have indicated that LNG might be safe and effective for pregnancy prevention as a pericoital product, and the World Health Organization (WHO) has initiated multisite clinical trials to assess this. Larger Phase 3 clinical trials will be needed to gather more data on effectiveness and secure stringent regulatory approval for widespread use.
Product development and introduction
- Kidwell Drake J, Metzler M, et al. Critical pathway for developing and introducing a new type of oral contraceptive method (879 KB PDF). Presented at: 2011 International Conference on Family Planning, November 30, 2011; Dakar, Senegal.
- Goodyear L, Harner-Jay C, et al. PATH’s framework for product introduction [fact sheet]. Seattle: PATH; 2007.
Safety and efficacy of levonorgestrel (LNG) for pericoital use
- Halpern V, Raymond EG, et al. Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy (Review) (562 KB PDF). The Cochrane Collaboration; 2010, Issue 5.
- WHO. Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs) [fact sheet] (268 KB PDF). Geneva: WHO; 2010.
- Rosenhaus M. Morning After? Day Before? Not So Fast… RH Reality Check website.
Repeat use of emergency contraception
- Westley E, Gold E, et al. Revitalizing the EC Agenda: Identifying Opportunities, Gaps and Barriers to Emergency Contraception Access in Developing Countries. Panel presented at: 2011 International Conference on Family Planning, December 1, 2011; Dakar, Senegal.
- Keesbury J, Morgan G, et al. Is repeat use of emergency contraception common among pharmacy clients? Evidence from Kenya. Contraception. 2011; 83:346–351.
- Reproductive Health Technologies Project. Emergency Contraception: Safe for Repeat Use? (42 KB PDF). Washington, DC; 2006.
- Abuabara K, Becker D, et al. As often as needed: appropriate use of emergency contraceptive pills. Contraception. 2004; 69:339-342.
- International Consortium for Emergency Contraception. Repeated Use of Emergency Contraception: The Facts [policy statement] (222 KB PDF). New York: ICEC; 2003.
Posted March 23, 2012.