Ovatech Closes Patient Enrollment In Phase 2 Trial Of Ovaprene

Ovaprene is a ‘one-size-fits-all’ patented, intravaginal organic silicone ring barrier-contraceptive that is designed to continuously release spermiostatic and spermicidal non-drug agents over a four-week period.

Reportedly, a Phase 1 safety-and-tolerability study conducted at NYDH concluded that ‘the Ovaprene device is well-tolerated and acceptable to sexually active women and their partners.’ The study (A Pilot Safety and Tolerability Study of a Non-Hormonal Vaginal Contraceptive Ring) has been published in The Journal of Reproductive Medicine.

In the published Phase 1 study, 20 female volunteers were instructed in proper insertion of the ‘one-size-fits-all’ Ovaprene ring at completion of menses—with removal at onset of subsequent menses. All Ovaprene rings were retained in place, including post-coitus.

In the trial the patients did not report pain, bleeding or discharge. Post-coital tests demonstrated theoretical contraceptive efficacy. All participants were willing to use, and recommend the product, during sexual intercourse in the future, including their male partners.

Ovatech said that if approved, Ovaprene would be expected to compete very favorably against the existing barrier contraceptives, including the ‘gold standard’ diaphragm and a hormone-based vaginal ring.

Ovatech is also expected to earn market share from oral contraceptives, IUDs (intrauterine devices), as well as attract new users. Ovaprene is designed to offer a non-systemic, female-controlled birth control option without the need for partner consent or approval.

John Williams, president and CEO of Ovatech, said: “Ovaprene represents an entirely new birth control method. We are looking forward to concluding our Phase 2 study at NYDH in a timely manner so that we can then ask the FDA for approval to commence our Phase 3 pivotal trial this year.”