Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the Company provided sufficient data to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.
https://finance.yahoo.com/news/dar-bioscience-announces-ide-approval-120000143.html
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