NICHD:R&D: OVAPRENE PHASE 1: PROTOCOL FINALIZATION, REGULATORY APPROVAL, START-UP, AND COMMENCEMENT OF RECRUITMENT, SCREENING, AND ENROLLMENT FOR THE OVAPRENE VAGINAL DEVICE CLINICAL TRIAL (NON-SEVER

Oregon Health & Science University, Portland OR

Investigators

Abstract

Ovaprene is a monthly hormone-free contraceptive product intended for the use in women of childbearing age. It is designed to reside in the vagina, covering the external os of the cervix, and consists of a vaginal ring with an incorporated knitted polymer matrix insert. It is inserted at the end of menses, removed at the onset of next menses, and a new Ovaprene is inserted at the end of that menses. The physical dimensions were designed to enable ease of intravaginal placement and maintenance of position in the vagina, and to create a “one size fits most” contraceptive product. NICHD has a mission to develop safe and effective contraceptives for women. Market research suggests that Ovaprene will be attractive to women who desire a hormone-free, user-controlled contraceptive alternative, and who want the improved convenience of a monthly option. A prior multi-center, open label, non-significant risk device study demonstrated that Ovaprene successfully reduced the number of sperm from penetrating midcycle cervical mucus. The ring component is comprised of a liquid silicone rubber medium that contains ferrous gluconate (FG), which causes oxidative damage and promotes lipid peroxidation, ultimately leading to spermiostasis. Thus, it is the novel combination of the spermtrapping polymer matrix and the local activity of a spermiostatic agent that work together to impart the Ovaprene contraceptive activity for up to 29 days of use. To provide evidence that Ovaprene could be effective for contraception, a clinical trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The proposed study will be a multi-center, single arm, open label study of the use of Ovaprene in women of reproductive age and will evaluate the effectiveness, safety, and acceptability of a hormone-free intravaginal product. The total anticipated duration for each subject is approximately 13-14 months: screening and enrollment for approximately 1 month followed by a treatment phase of 12-13 months. Approximately 700 women are expected to enroll, and this will generate over 5000 cycles of safety exposure. Scope: To finalize protocol development, obtain regulatory approval, start-up, and commencement of recruitment, screening, and enrollment of eligible subjects for a study involving Ovaprene, a monthly hormone-free vaginal device. Objective: To participate in protocol finalization, start-up activities, procurement of regulatory approval, and initiation of the recruitment, screening, and enrollment of suitable subjects for a clinical trial to evaluate the contraceptive efficacy and safety of Ovaprene, a monthly hormone-free contraceptive barrier.