DARE - Daré Bio inks research deal for Phase 3 study of contraceptive Ovaprene
Daré Bioscience (DARE) has entered into a Cooperative Research and Development Agreement ((CRADA)) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development ((NICHD)), for the Phase 3 study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive currently in clinical development for the prevention of pregnancy.If approved, Ovaprene could be the first monthly non-hormonal contraceptive option for women. Daré will be responsible for providing clinical supplies and coordinate with and submit supportive regulatory documentation to the FDA.NICHD will be responsible for other costs and will manage the payment of expenses to Health Decisions, the clinical sites, and other parties involved with the study.The Phase 3 Ovaprene study will evaluate its effectiveness as a contraceptive device along with its safety and usability. Daré plans to file an IDE for Ovaprene in Q4 2021 and, pending the FDA’s review and clearance, will initiate the study in 2022. Under the CRADA, Daré has
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Daré Bio inks research deal for Phase 3 study of contraceptive Ovaprene