A substantial proportion of women in developing countries with an unmet need for family planning cite infrequent sex as a reason for not practicing contraception: 6-39% of women with unmet need in Sub-Saharan Africa and 14-35% in South and Southeast Asia.1 Notably, about one in four adolescent women aged 15-19 with unmet need report that they are not using a method because they do not have sex frequently. 2 For women who have infrequent sex, an oral contraceptive pill taken only at the time of intercourse may offer advantages in terms of convenience and ease of use; because this method is discreet and female-controlled, it may appeal to other women as well. Pericoital contraceptive pills-also referred to as "ondemand" or "real-time" contraceptives-are being considered as a way to address unmet need, especially among women who have sex no more than six times a month. There is currently no oral contraceptive pill marketed for such use. Women could take a pericoital contraceptive pill within 24 hours before or after intercourse, rather than daily. Levonorgestrel, one compound being considered as the active component in a pericoital pill, is a synthetic progestin that has been used as an active hormonal ingredient in daily birth control pills for about 40 years. It is also the key ingredient in contraceptive implants, hormone-releasing IUDs and emergency contraceptive pills. Levonorgestrel is off-patent and has a good safety profile.
3Studies from a number of countries suggest that some women are already using emergency contraception offlabel as an on-demand pill, demonstrating latent demand for a pericoital method.4-6 Women who do not have sex frequently are particularly likely to use emergency contraception as their regular method. 4 Moreover, a survey of women in urban Nigeria found that those who reported having used emergency contraception had done so an average of five times in a six-month period. 7 Interviews with WestAfrican women using emergency contraception as a regular method reveal a preference for the convenience of an "occasional pill" and for episodic, rather than sustained, exposure to hormones (reflecting their safety concerns about hormones that remain in the system). 8 These studies show that in the absence of a coitus-related, female-controlled contraceptive method that does not interrupt sexual activity and is labeled and marketed for routine use, women have adapted an existing method to meet that need. There are obvious similarities between a potential pericoital contraceptive product and currently available emergency contraception; for example, both are coitus-related methods, and the same active ingredient may be used for both. That said, a dedicated pericoital pill would be labeled and marketed for use within 24 hours before or after sex, as a routine contraceptive method. While repeat use of levonorgestrel does not pose any known health risks,