Reproductive Health Global Program

A new type of oral contraceptive pill

Assessing potential demand

Woman standing in doorway.

In 2012, PATH conducted two studies to explore women’s, men’s, and key stakeholders’ perspectives on this potential innovation in India and Uganda. Photo: PATH/Lesley Reed.

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 relatively less frequent sex (e.g., six times per month or less), 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. In 2012, PATH received funding from Gynuity (and applied 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 conducted focus group discussions and in-depth interviews with potential end-users (women and men), family planning providers, and key opinion leaders. These discussions explored the appeal of this new method among various market segments, as well as the enabling and inhibiting factors for product supply.

Consumer perceptions were generally favorable: women appreciated the hypothetical convenience of not having to take a daily pill; flexible timing; and the potential for female control and even secret use, if necessary. They did have questions about what the side effects and impacts on fertility might be, which echoed their concerns about hormonal contraception in general. Providers and key opinion leaders in both countries also had many questions about this new method, but those in India tended to respond somewhat more favorably to the promise of this method to expand the range of contraceptive options available for women.

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 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.

Related resources

Product development and introduction

Safety and efficacy of levonorgestrel (LNG) for pericoital use

Repeat use of emergency contraception

Posted March 23, 2012.