Dare Bioscience, Inc. 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 ovarian-free 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 Ovaprene is approved by the U.S. Food and Drug Administration (FDA), it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women in the U.S. seeking a hormone-free, self-administered and monthly birth control method. Ovaprene is an investigational hormone-free, intravaginal monthly product candidate currently in clinical development for pregnancy prevention. Ovaprene releases a locally acting, non-hormonal agent which impedes sperm motility and features a proprietary knitted polymer barrier to physically block sperm from entering the cervical canal.

Ovaprene completed a successful postcoital test (PCT) clinical study where, in all women and across all cycles evaluated, it prevented virtually all sperm from entering the cervical canal, a surrogate marker for contraceptive effectiveness. The results from the PCT clinical study support continued clinical development of Ovaprene and its potential to be the first hormone-free, monthly contraceptive option for women.