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FDA to Review One-year Vaginal Ring

© The Population Council
© The Population Council

The U.S. Food and Drug Administration (FDA) has accepted for review a contraceptive vaginal ring developed by the Population Council.  If approved, the ring would be the first contraceptive fully under a woman’s control to provide a full year of pregnancy protection.

The ring combines a well-known estrogen—ethinyl estradiol—with a new progestin, Nestorone.® Women self-insert the soft, flexible 2 ¼-inch silicone ring, leaving it in place for 21 days, removing for 7 days, and then repeating the process over an entire year (13 menstrual cycles).  The ring does not require refrigeration, a key consideration when distributing contraceptives in low-resource settings.

The FDA review will be based on data from 17 clinical trials, including two pivotal Phase III trials with 2,308 women across 27 study sites worldwide.  The U.S. Agency for International Development, the Eunice Kennedy Shriver National Institute for Child Health and Human Development, the Bill & Melinda Gates Foundation, the Avis and Clifford Barrus Medical Foundation, and the World Health Organization financially supported the product development efforts.