Ovatech Reports Enrollment is Closed for Phase 2 Clinical Trial of Ovaprene Non-Hormonal Intravaginal Contraceptive Ring at New York Downtown Hospital (NYDH)
Phase 1 Ovaprene data published in The Journal of Reproductive Medicine
“As a potential new birth control method, Ovaprene might be one of the most important advances for women's health.” - Susan Richman, MD, MPH, Associate Clinical Professor, Obstetrics and Gynecology, Yale University School of Medicine
AUBURNDALE, Mass.--(BUSINESS WIRE)--Mar 18, 2010 - Ovatech, an emerging women's health-focused company, announced today that enrollment has closed for the Company's Phase 2 clinical study of its non-hormonal, intravaginal contraceptive ring, Ovaprene. The study is being conducted at New York Downtown Hospital (NYDH), a member of the New York-Presbyterian Healthcare System. 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.
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. Principal investigator for the study was Giuseppe Del Priore, MD, formerly Vice President of Research and Chairman of the Institutional Review Board (IRB) at New York Downtown Hospital.
“The potential of Ovaprene as a non-hormonal, coitus-independent contraception device cannot be overstated,” said Jeanetta Stega, MD, PhD, Vice President of Research and Chairman of the Institutional Review Board (IRB) at NYDH.
“As a potential new birth control method, Ovaprene might be one of the most important advances from a public health standpoint for women's health,” added Susan M. Richman, MD, an adviser to Ovatech for both the Phase 1 and Phase 2 clinical studies of Ovaprene.
“Ovaprene represents an entirely new birth control method,” said John A. Williams, President and CEO of Ovatech. “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.”
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. 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.
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. In 2002, 98 percent of women who had ever had intercourse had used at least one method of contraception; of women 15 to 44 years old, 62 percent were currently using contraception.
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. Ovaprene also is 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.
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.
Contact: Ronald Trahan Associates Inc.
Ronald C. Trahan, +1-508-359-4005, x108
Posted: March 2010