Daré Bioscience Receives IDE Approval for Ovaprene Study
The FDA has approved Daré Bioscience’s Investigational Device Exemption (IDE) application for Ovaprene, a hormone-free intravaginal contraceptive.
The IDE submission was supported by results of a previous clinical study in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated.
The FDA has provided additional study considerations for the IDE-approved study so it will be the primary clinical support for a future marketing approval or clearance.
The company said it will review the agency’s recommendations with its collaborators, Bayer and the National Institutes of Health. Recruitment for the study is expected to begin in mid-2023.