Today, the Population Council presented findings from a Phase 3 clinical trial that was designed to demonstrate the safety, efficacy, and acceptability of the Council's investigational one-year contraceptive vaginal ring (CVR). The results were presented during an oral session at the 69th Annual Meeting of the American Society of Reproductive Medicine.
The study presented today (Study 300B) is part of an extensive clinical trial package that will be submitted as part of a New Drug Application to the U.S. Food and Drug Administration. The application will include two pivotal Phase 3 clinical trials conducted with more than 2,000 women across 27 study sites worldwide. Study 300B evaluated the contraceptive efficacy, safety, and acceptability of the CVR, and Study CCN006/300A evaluated efficacy and safety. The studies were conducted in partnership with the U.S. Agency for International Development (USAID); the World Health Organization (WHO); and the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Contraceptive Discovery and Development Branch.
Study 300B was a multicenter, open-label trial that involved more than 1,100 healthy, normally ovulating women across 12 study sites in Australia, Europe, Latin America, and the United States. Preliminary results suggested that the CVR-a type of long-acting, reversible contraceptive (LARC)-is as effective as other combined hormonal contraceptives in preventing pregnancy when used as directed. Preliminary results also suggested that the safety profile is consistent with that of available combined hormonal contraceptives.
In addition to evaluating contraceptive efficacy and safety, Study 300B assessed women's acceptance of the CVR. The study found that women were highly satisfied with the ring, found it easy to use, and indicated that they would recommend it to other women. The ring was also well-accepted by their partners.