Recent advances in barrier contraception: Review and report of clinical trial of the oves® cervical cap

A brief history and comparison of barrier methods of birth control are reviewed. The clinical trial of the Oves® cervical cap, a new barrier method for contraception, is reported. The aim of this study was to evaluate the safety and effectiveness of the Oves® cervical cap. The Oves® cervical cap is made of implantable grade silicone which fits snugly over the cervix. Women (N= 17) included in the study were followed at 3-months, 6-months and annually during their participation in the study, for a total of 336 women-months. Clinical data consisted of Pap smear at the initial exam, at 3 months, and annually thereafter. Women completed a monthly diary of side effects and history of their use of the cap with sexual activity. Personal use diaries were tabulated for reported side effects. Data were analysed using standard life-expectancy table analysis to determine contraceptive effectiveness rates. Results showed that the contraceptive failure rate was low, the Oves® cervical cap in this study had a contraceptive effectiveness rate of 100%. There were no serious or severe side effects. Reported side effects consisted of vaginal infection (11 cases in five women) and dislodgement (5 cases). Only one subject discontinued use of the Oves® cervical cap because of discomfort. Overall, women and their partners reported satisfaction with use of the Oves® cervical cap. The major limitation of this study was the small sample size. Current efforts are underway to undertake a larger clinical trial in attempt to win FDA approval to market the device in the US.