AUBURNDALE, Mass.--(BUSINESS WIRE)--Ovatech, an emerging women’s health-focused company, announced today that the Company’s Phase 2 clinical study of its non-hormonal, intravaginal contraceptive ring, Ovaprene, has been successfully completed. Ovaprene is a ‘one-size-fits-all’ patented, female-controlled, intravaginal organic silicone ring barrier-contraceptive that is designed to continuously release spermiostatic and spermicidal non-drug agents over a four-week period.
In the Phase 2 study, eighty-five (85) females participated and were instructed in the proper insertion of the one-size-fits-all Ovaprene ring at completion of menses—with removal at onset of subsequent menses; this protocol was observed once a month for three months for each study participant. All Ovaprene rings were retained in place, including post-coitus. To date, including Phase 1 data, 300+ post-coital tests of study-participants’ cervical pool have been analyzed, with zero motile sperm in the active ring study group. All participants were willing to use and recommend the product during sexual intercourse in the future, including their male partners. The final Phase 2 results were consistent with the preliminary Phase 2 data reported in May at the 2010 Annual Meeting of the American Congress of Obstetricians and Gynecologists (ACOG).
“Ovaprene is designed to be a whole new paradigm for birth control,” said John A. Williams, President and CEO of Ovatech. “We look forward to starting our Phase 3 pivotal trial as soon as possible.”
Ovaprene is designed to offer a non-systemic, female-controlled birth control option—without the need for partner consent or approval. Contraceptives and contraceptive devices are likely the most widely used medical devices in the world, with $22 billion spent on contraception in the U.S. market annually. In the U.S., 42 million women—or 7 in 10 women ages 15 to 44—are currently sexually active and do not want to become pregnant.
A Phase 1 safety-and-tolerability study 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”) was published in The Journal of Reproductive Medicine.
Ovatech Inc., based in Auburndale, Mass., is an emerging medical technology company that is focused on products to enhance women’s health. In addition to Ovaprene, there are four additional, important products from the Company’s proprietary platform.
CAUTION: Ovaprene is for investigational use only and is not for sale in the United States.