The FDA has approved Female Health Company's FC2 Female Condom (FC2), a woman-initiated barrier method that helps protect against unintended pregnancy, HIV/AIDS, and other sexually-transmitted infections (STIs). This approval is based on data from a randomized, double-blind, crossover, comparative trial of FC2 with FC1, which is Female Health Company's first-generation FC Female Condom. The results showed FC2 to be safe and that the risk of FC2 failure modes during use was comparable to FC1.