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Female Condom Research Briefs Series — No. 2:

Effectiveness for Preventing Pregnancy and Sexually Transmitted Infections

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Pregnancy prevention

The female condom is an effective contraceptive if used consistently and correctly. Within the first year of consistent and correct use, about 5 percent of women relying on the female condom will have an unintended pregnancy, compared to 2 percent for male condoms and 6 percent for the diaphragm with spermicide. When use is not always correct or consistent, the unintended pregnancy rate has been estimated at 21 percent for the female condom, compared to 15 percent for the male condom.1 These rates are based on the six-month gross cumulative pregnancy rate among 221 US women participating in a three-country female condom effectiveness study.2

Smaller studies also suggest that the pregnancy protection offered by female condoms is similar to that provided by male condoms. A 1992 study from the United Kingdom involving 106 women for various lengths of time (a total of 441 months of observation) reported a 12-month pregnancy probability of 15 percent with typical use.3 A 1998 study from Japan found a six-month pregnancy probability of 1 percent when used consistently and correctly and of 3 percent under typical use.4 In Japan, where the male condom is the predominant method of family planning, familiarity with male condoms may have contributed to higher effectiveness rates with female condoms.

STI prevention

Laboratory studies have found female condoms impermeable to various sexually transmitted infections (STIs), including HIV.5 In theory, the device should reduce the risk of STI transmission in human contact, but more research is needed to confirm its effectiveness. Because its outer ring partially covers the external genitalia, the female condom may provide more protection against genital ulcer infections, such as herpes and chancroid, than the male condom does. Using female condom contraceptive effectiveness data and mathematical modeling, a study estimated that perfect use of the female condom might reduce the annual risk of acquiring HIV by more than 90 percent for a woman who has intercourse twice weekly with an HIV-infected man.6

One human study has found that the female condom protects against trichomoniasis, the most common curable STI in the world. One hundred and four women who had been previously diagnosed and treated for trichomoniasis were offered female condoms. Those who said they would use the device consistently were put in the "user" group; the others were assigned to the comparison group. None of the 20 women who used the female condom consistently for 45 days became reinfected, compared to 15 percent reinfected among those in the user group who used it inconsistently (5 of 34) and 14 percent reinfected among those who used no protection (7 of 50).7

Three randomized controlled trials, conducted in the United States, Thailand and Kenya, found that distributing female condoms along with male condoms offered at least as much STI protection as providing male condoms alone. Two of these studies suggest that providing access to female condoms may even offer additional STI protection over that provided by male condom distribution; however, those differences were not large enough to draw a definitive conclusion, while the largest of the three trials showed no added benefit.8

In the US study, 1,442 STI clinic clients were randomly assigned to receive training, support, and supplies for use of either female or male condoms and were followed for almost a year. This study was not a direct comparison between female and male condoms, because some women receiving female condoms from the study also used male condoms. Data analysis revealed that study participants receiving female condoms had a slightly reduced risk of acquiring a new STI compared with those receiving male condoms. Although this result was not statistically significant, the study did show that women counseled on and provided female condoms are at least as protected as women provided male condoms alone.9

The study in Thailand measured gonorrhea, chlamydial infections, trichomoniasis and genital ulcers among 504 sex workers over 24 weeks. Those randomly assigned to have access to both male and female condoms had an incidence of 2.8 STIs per 100 women per week. Those with access to male condoms only had 3.7 STIs per 100 women per week. While the difference between 2.8 and 3.7 suggests that the availability of the female condom lowers STI infection rates, the results were not statistically significant.10 Low overall rates of STIs already existed at these sites, due to their participation in the 100 percent male condom program in Thailand.11

In contrast, the Kenya study failed to show that the availability of female condoms, along with male condoms, affects STI rates, compared to the availability of only male condoms. Like the Thailand study, the Kenya study was a randomized controlled trial, but it had a much larger sample size of 1,600 women. At both control and intervention sites, about 24 percent of the women had gonorrhea, chlamydia or trichomoniasis at baseline. After 12 months, the rates of these STIs had declined to 18 percent in both intervention and control sites.12 (For more information, see Female Condom Research Brief Number 7.)

A recent study in Madagascar did show an added benefit from female condom provision, but it was not a randomized trial. In this study, 1,000 sex workers were first exposed to a six-month male condom intervention, followed by 12 months of male and female condom promotion and distribution. During the first six months, the proportion of the women testing positive for at least one of three STIs dropped from 53 percent to 49 percent. With the addition of female condoms, STI prevalence decreased further to 41 percent after 12 months, leveling to 40 percent after 18 months. This statistically significant decline in STI prevalence cannot necessarily be attributed to female condom availability because the study did not include a comparison group that had access to male condoms only. However, the steep drop in STI prevalence that occurred after female condom introduction suggests that the device's addition to the method mix produced a public health benefit.13

Endnotes

  1. Trussell J. The essentials of contraception: efficacy, safety, and personal considerations. In Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology, Eighteenth Revised Edition. (New York: Ardent Media, Inc., 2004)221-52.
  2. Farr G, Gabelnick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. Am J Public Health 1994;84(12):1960-64; Trussell J, Sturgen K, Strickler J, et al. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect 1994;26(2):66-72.
  3. Bounds W, Guillebaud J, Newman GB. Female condom (Femidom). A clinical study of its use-effectiveness and patient acceptability. Br J Fam Plann 1992;18(2):36-41.
  4. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58(3):147-48.
  5. Drew WL, Blair M, Miner RC, et al. Evaluation of the virus permeability of a new condom for women. Sex Transm Dis 1990;17(2):110-12.
  6. Trussell, 1994.
  7. Soper DC, Shoupe D, Shangold GA, et al. Prevention of vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis 1993;20(3):137-39.
  8. French PP, Latka M, Gollub E, et al. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis 2003;30(5):443-39; Fontanet A, Saba J, Chandelying V, et al. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trials. AIDS 1998;12(14):1851-59; Feldblum P, Kuyoh MA, Bwayo JJ, et al. Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya. AIDS 2001;15(8):1037-44.
  9. French.
  10. Fontanet.
  11. Rojanapithayakorn W, Hanenberg R. The 100 percent condom program in Thailand. AIDS 1996;10(1):1-7.
  12. Feldblum.
  13. Deperthes B, Hatzell-Hoke T. Effectiveness of female condoms in the prevention of pregnancy and sexually transmitted infections. Global Consultation on the Female Condom, September 26-29, 2005.

FHI produced these research briefs as part of an information dissemination effort supported by the Bureau for Africa/Office of Sustainable Development, U.S. Agency for International Development.