Dare Bioscience (NASDAQ:DARE) completed patient recruitment for a postcoital test (PCT) trial of Ovaprene, a self-administered, hormone-free, contraceptive intravaginal ring.
Ovaprene consists of a permeable polymer matrix barrier in the center of a small silicone ring, which releases ferrous gluconate to impede sperm motility.
“We believe the positive data from a prior PCT trial published in the Journal of Reproductive Medicine, which demonstrated Ovaprene was successful at blocking sperm from entering the cervical canal, coupled with the high investigator and patient interest in this more robust pre-pivotal PCT trial that we have been conducting, suggest a significant market opportunity for a monthly, woman-controlled, hormone-free contraceptive,” Sabrina Martucci Johnson, Dare’s president and CEO, said in a statement.
Dare expects to report topline data from this study in the fourth quarter of 2019. Should Ovaprene demonstrate less than five progressively motile sperm per high powered field in the cervical canal in most women, as well as safety over multiple weeks, Dare intends to file an investigational device exemption with the FDA to commence a pivotal clinical trial.
