Daré Bioscience Announces Commencement of Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

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[{"type":"text","content":"Ovaprene has the Potential to be the First FDA-Approved Monthly, Self-Administered, Hormone-Free Contraceptive Product\nSAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive. The multi-center, single arm, non-comparative, pivotal Phase 3 clinical study of Ovaprene will evaluate its effectiveness as a contraceptive along with its safety and usability. The study aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use, with updates on anticipated study completion expected as enrollment progresses. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries. “While we’ve seen improvements in hormonal contraception over the last 20 years, many women need more options and innovation in non-hormonal contraceptive methods,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Ovaprene is a hormone-free monthly contraceptive that has disruptive, first-in-category potential based on its convenient use that doesn’t require action at the time of intercourse and its unique mechanism of action, which based on the results of the pre-pivotal study, is expected to deliver efficacy approaching hormonal methods. Commencing our pivotal Phase 3 study marks an important milestone in the Ovaprene program as we strive to advance this innovative contraceptive option that women want and need.” In July 2021, Daré entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to collaborate on the pivotal Phase 3 study of Ovaprene. The agreement gives Daré access to the contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal study with the NICHD. In January 2020, Daré and Bayer announced an exclusive licensing agreement for U.S. commercial ri...

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