Research affirms female condom’s effectiveness
A new study of the Reality female condom finds that the method, when used consistently and correctly, offers higher levels of contraceptive efficacy than shown in previous research.1
In an analysis of use among 190 Japanese women, the female condom, manufactured by the Female Health Company of Chicago, demonstrated a six-month life table probability of pregnancy of 3.2% during typical use and 0.8% during perfect use. (Pregnancy rates during typical use reflect how effective methods are for the average person who does not always use methods correctly or consistently, according to Contraceptive Technology.2 Pregnancy rates during perfect use reflect how effective methods can be when used consistently and correctly.)
The study, conducted by James Trussell, PhD, associate dean of the Woodrow Wilson School of Public and International Affairs at Princeton (NJ) University, was completed as part of the Female Health Company’s efforts to gain market approval in Japan. Final approval had not been announced at Contraceptive Technology Update’s press time.
Women who used the female condom in the Japanese efficacy trial found it a highly acceptable (11.8%), acceptable (41.5%), or somewhat acceptable (35.9%) method of birth control. About 8% found it not very acceptable, with 3.1% deeming it undesirable.
About 85% of couples in Japan rely on barrier methods for contraception, says Mary Ann Leeper, PhD, president and chief operating officer of the Female Health Company. Approval of the Reality condom in Japan would open doors to a very significant market, she notes.
The Reality female condom demonstrated a higher level of contraceptive effectiveness in the Japanese trial than in two previous studies. The first clinical trial of the condom, conducted in the United Kingdom, reported a 15% typical use rate based on a 12-month life table probability of pregnancy.3 A second multinational trial recorded a six-month typical use rate at 12.4% in the United States and 22.2% in Latin America.4 Perfect use rates during this trial were 2.6% in the United States and 9.5% in Latin America.
Ten centers participated in the Japanese study, with participants expected to use the female condom as their only form of birth control for six months. All women were required to be between ages 20 and 40 at enrollment and have an average coital frequency of at least four times per month. Of the 190 women in the efficacy analysis, 11 did not complete the study. Six became pregnant, and five discontinued due to other reasons. Of the six pregnancies, only one occurred despite consistent and correct use.
Trussell points out that differences across studies in pregnancy rates during typical uses are primarily affected by the extent and type of imperfect use. In comparing perfect use rates, one must keep in mind the influence of the fecundity of the couple and coital frequency. A woman becomes less fertile as she ages, and coital frequency declines with age and marital duration.
While the mean ages of the women in all three studies were similar (26 in Latin America, 29 in the United States, 21 in the United Kingdom, and 32 in Japan), numbers for average coital frequency differed. The mean coital frequency for women in the Japanese trial was 4.9 times per month, 59% lower than the 12.0 recorded among U.S. women. This low frequency rate may attribute to the reduced risk of pregnancy during perfect use in the Japanese trial, says Trussell.
Women embrace Reality
The Reality female condom continues to gain acceptance around the globe, says Leeper. Unit sales increased 91% during the fourth quarter of 1998 to 2.1 million units, up from 1.1 million units during the same period in 1997, according to company press reports.
Markets in Zimbabwe, Zambia, Cote d’Ivoire, Bolivia, Haiti, and South Africa were opened in 1998, with future launches expected to include Tanzania, Kenya, Nigeria, Uganda, Columbia, and Central American countries. In the United States, the company’s customer list has expanded to include 10 major cities and 15 states, including Miami, Washington, DC, Chicago, Houston, Phil adelphia, Illinois, New York, New Jersey, Connec ticut, Florida, Pennsylvania, and Washington.
The Female Health Company has developed a new training manual for trainers and outreach counselors to use in teaching women about the female condom says Leeper. (See resource listing, above right, for more information.)
"We are doing a lot of programs with community-based organizations that are playing a more increased role in prevention of both unintended pregnancy, as well as STDs," she reports. "They are going into the communities, developing programs, and talking among their peers about practicing safer sex, so we have developed educational materials for them."
Young adults who have been educated on the importance of safer sex represent a significant segment of the female condom market, she says. Once they learn about the method, young people are very receptive to trying the Reality condom, and the majority continue to use it, she notes.
References
1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York: Ardent Media; 1998.
2. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998; 58:147-148.
3. Bounds W, Guillebaud J, Newman GB. Female condom (Femidom). A clinical study of its use-effectiveness and partner acceptability. Br J Fam Plann 1992; 18:36-41.
4. Farr G, Gabelnick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. Am J Public Health 1994; 84:1,960-1,964.
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