When it comes to contraception, women value convenience and efficacy. Most women would prefer a contraceptive method they don’t need to remember to take every day and that doesn’t require action at the time of intercourse. Additionally, survey data showed that nearly 85% of women would prefer a monthly option with a lower hormone dose than the oral birth control pill. We at Daré are working to offer women a contraceptive option with these features.
Ovaprene® is an investigational hormone-free monthly intravaginal contraceptive designed to be worn conveniently over multiple weeks (one menstrual cycle) and prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones.
In a postcoital test (PCT) study, Ovaprene® successfully immobilized sperm and prevented their progression into the cervical canal. Based on the positive results of this study, we intend to file an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2021, and, pending the FDA’s clearance of the IDE, to initiate the pivotal Phase 3 study of Ovaprene® in 2022.
In July 2021, we announced that we entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene®. The agreement will allow us to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene® will evaluate its effectiveness as a contraceptive device along with its safety and usability. If successful, we expect the pivotal study to support marketing approvals of Ovaprene® in the U.S. and other countries. If Ovaprene® is approved by the FDA, it could be the first monthly non-hormonal contraceptive option for women and a first-in-category therapy for women seeking a hormone-free, self-administered and non-invasive birth control method.