Silicone rubber Femcap proves desirable to women

Contracept Technol Update. 1993 May;14(5):78-80.

Abstract

PIP: A barrier contraceptive is in the preliminary stages of investigation according to a recent acceptability study. 106 participants were asked to rate their satisfaction with Femcap, an anatomically designed intravaginal device. Women chosen for the trial were ages 18 to 40 who were dissatisfied with other birth control methods. The study was underway for almost 3 years during which participants were asked to keep a diary noting any side effects and the dates of their menses. A physical and pelvic examination, Pap smear, pregnancy test, and screening for sexually transmitted diseases were performed at the initial visit. Among the most desirable features, cited by more than 80% of the women, were the lack of hormones, the absence of health-related side effects, and Femcap's silicone rubber composition. The device proved to have an overall effectiveness of 95.2%, with a 4.8% probability of failing to prevent pregnancy within 1 year. Femcap's developer, Alfred A. Shihata, used these acceptability criteria for women: the device should be able to be placed hours before intercourse, removed hours after intercourse, and it should not interfere with the spontaneity of sex. There are 3 design mechanisms of Femcap that work together to prevent sperm from entering the cervix: the brim, the rim, and the dome. The device is available in 3 sizes. Phase II clinical trials of Femcap were scheduled to begin in June 1993, with about 400 women to be studied at 6 sites for 6 months to a year, according to Shihata. The Femcap kit will contain 2 Femcaps which can last up to 3 years along with the instructional video, and illustrated brochure, a tube as well as several packages of spermicide, and even 4 emergency postcoital pills. The new device may be available within 2 years, and the kit will probably cost about $75 to $80.

MeSH terms

  • Americas
  • Contraception Behavior
  • Contraception*
  • Contraceptive Agents
  • Developed Countries
  • Family Planning Services
  • North America
  • Patient Acceptance of Health Care*
  • Spermatocidal Agents*
  • United States

Substances

  • Contraceptive Agents
  • Spermatocidal Agents