Dare Bioscience (DARE) announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene, the company’s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives. The trial’s independent Data Safety Monitoring Board conducted a planned interim analysis focused on reviewing safety data from the study, and recommended the study continue without modification. At the time of the interim analysis, approximately 9% of the women treated in the study had experienced a pregnancy, a rate consistent with the company’s expectations based on the results of the pre-pivotal postcoital test clinical study of Ovaprene. These interim findings support Ovaprene’s potential as a meaningful hormone-free alternative.
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