Original Research ArticlesContraceptive efficacy of the Reality® female condom
Introduction
The Reality® female condom is a thin, soft, loose-fitting polyurethane sheath with two flexible rings. The inner ring aids in insertion and placement at the posterior fornix. The outer ring and about 1 inch of the sheath remain outside the vagina, partially covering the labia and the base of the penis during intercourse. As the vagina expands during intercourse, the slack of the sheath is taken up so that the outer ring lies over the labia. The device is marketed in 10 countries, including the United States, the United Kingdom, Korea, and Switzerland. In the United States, the Reality female condom is available without prescription in pharmacies in a box containing three female condoms prelubricated with silicone and three containers of extra water-based lubricant. The product is approved for one-time use only for prevention of pregnancy and—for those women whose partners will not use a male condom—sexually transmitted infection. This article reports the results of a clinical trial undertaken to evaluate the contraceptive efficacy and acceptability of the female condom (called TCF-3 in the trial) in Japan.
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Materials and methods
The trial was conducted at 10 centers throughout Japan from November 1994 to October 1995. Subjects were expected to use the female condom as their only contraceptive method for 6 months and were required to be between the ages of 20 and 40 years at enrollment, to have a coital frequency of at least four times a month on average, to be willing to complete coital diaries and acceptability questionnaires, to have normal ovarian function as judged by measuring and recording body temperature (or by
Results
Of 204 volunteers, 195 met the criteria for admission. Of the 195 subjects enrolled, 94.4% were married, 11.8% were nulligravid, 14.4% were nulliparous, and 95.9% had previously used male condoms; their average age was 32.0 years. No subjects were lost to follow-up. Participation of five subjects was discontinued by the investigator (two for inadequate coital frequency, two for using other contraceptive methods, and one for not providing coital diaries or usage feeling questionnaires); none of
Discussion
The Reality female condom demonstrated higher contraceptive efficacy in this trial than in two previous efficacy studies of this method; the 6-month life table probability of pregnancy was 3.2% during typical use and only 0.8% during perfect (correct and consistent) use of the device. In contrast, in the first clinical trial of the female condom, conducted in the United Kingdom, the 12-month life table probability of pregnancy during typical use was 15%.1 In a second trial, 6-month
Acknowledgements
The author has no financial interest in the commercial success or failure of the Reality female condom. The author is grateful to Kunio Kitamura, Director, Family Planning Clinic, Japan Family Planning Association, Inc, for generously providing the data.
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