Dare Bioscience commences Phase 3 study of Ovaprene

Dare Bioscience 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 of use, with updates on anticipated study completion expected as enrollment progresses. If successful, Dare 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 Dare 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.”