A pilot safety and tolerability study of a non-hormonal vaginal contraceptive ring

Abstract

To report preliminary data on the Ovaprene® device, a medical grade silicone ring that releases ferrous gluconate, ascorbic acid, and glycine in spermiostatic concentrations (Poly-Med Inc, Clemson University), designed for over the counter non-hormonal contraception. An open label short term pilot tolerability study in 20 paid volunteers. Women using another contraceptive method were eligible if they met the other inclusion criteria. Women were instructed in proper insertion of the ring at the completion of their menses, with removal at the onset of their subsequent menses or 29 days, whichever was shorter. PAP, vaginal cultures, colposcopy and post-coital testing were performed at daily to weekly follow-up. To date, 10 women have enrolled and 5 completed one cycle use (total observations approximately 100). All rings were inserted properly and retained in place including post-coitus (range 1–29 days). Patient questionnaire revealed no pain, bleeding or discharge. Male partners detected the device (2 partners of the 10 women). Wet mounts were normal. Semi-quantitative cultures showed no significant changes in genital flora. Vaginal pH was ≤4.5 except post-coitus (range 1–4 hours) was 4.5–6.5. All epithelium was intact. Random ferrous gluconate vaginal fluid concentrations during normal usage averaged 1438 ± 1028.93 μg/g. Post-coital test revealed sperm (motile/total, mean ct/10hpf) vaginal pool 2/>20; cervical mucous 0/0. One patient had odor for 24 hours after intercourse resolving spontaneously. All participants were willing to use and recommend the product during sexual intercourse in the future, as reported on the follow-up acceptability questionnaire. The Ovaprene® device is well tolerated and acceptable to sexually active women. Preliminary post-coital test demonstrates theoretical contraceptive efficacy. Additional data will be presented.