Although public health programs invest heavily in the male latex condom, its efficacy in preventing pregnancy and sexually transmitted disease has been based primarily on in vitro and retrospective studies.
We combine the results from two randomized, controlled contraceptive efficacy trials that used commercial latex condoms brands (Ramses Sensitol���, LifeStyles���, Trojan-Enz���) in the control arms. Combining data from the two studies, we obtained longitudinal data covering 3526 menstrual cycles contributed by approximately 800 couples who used latex condoms exclusively for up to six menstrual cycles. Both trials also collected 3715 detailed breakage and slippage reports from the first five study condom uses. The second trial also tested 243 postcoital vaginal samples collected after the first study condom use for the presence of prostate-specific antigen (PSA) and spermatazoa.
The combined clinical breakage rate for the first five condom uses was 0.4% for the three latex brands and the combined clinical slippage rate was 1.1%. The combined six-cycle typical-use pregnancy rate for the latex condoms was 7.0% (95% confidence interval 5.0���9.0). The combined six-cycle consistent-use pregnancy rate was 1.0% (95% confidence interval 0.0���2.1). PSA was detected in only 1.2% of postcoital vaginal samples collected after the first use of an intact study condom. There were no differences in performance or efficacy among the three latex brands tested.
The male latex condoms rarely broke or slipped off during intercourse and provided high contraceptive efficacy, especially when used consistently. Risk of semen leakage from intact condoms was very low.
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- The effectiveness of condoms in reducing heterosexual transmission of HIV.Fam. Plann. Perspect. 1999; 31: 272-279
- Latex condom breakage and slippage in a controlled clinical trial.Contraception. 1997; 56: 17-21
- Breakage and acceptability of a polyurethane condom: a randomized, controlled study.Fam. Plann. Perspect. 1998; 30: 73-78
- Comparative evaluation of three Tactylon��� condoms and a latex condom during vaginal intercourse: breakage and slippage.Contraception. 2000; 61: 205-215
- Randomized crossover trial comparing the eZon plastic condom and a latex condom.Contraception. 2001; 63: 25-31
- Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.Fam. Plann. Perspect. 1999; 31: 81-87
- Condom slippage and breakage rates.Fam. Plann. Perspect. 1992; 24: 20-23
- Condom performance during vaginal intercourse: comparison of Trojan-Enz��� and Tactylon condoms.Contraception. 1992; 45: 11-19
- Lack of latex porosity: a review of virus barrier tests.J. Rubber Res. 1999; 2: 29-39
- An in vitro evaluation of condoms as barriers to a small virus.Sex Transm. Dis. 1997; 24: 161-164
- Implications of laboratory test of condom integrity.Sex Transm. Dis. 1999; 26: 216-220
Workshop summary: scientific evidence on condom effectiveness for sexually transmitted disease prevention. National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services 2001; 1���27.
- Evaluation of prostate-specific antigen as a quantifiable indicator of condom failure in condom trials.Contraception. 1999; 60: 289-298
- Objective markers of condom failure.Sex Transm. Dis. 1998; 25: 427-432
- Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure.Contraception. 1999; 59: 195-201
- Estimation of semen exposure from post-coital vaginal samples tested for prostate-specific antigen (PSA) and sperm following male condom failures: implications for contraceptive efficacy and prevention of sexually transmitted disease.Contraception. 2003; 67: 139-150
- Evaluation of the efficacy of a nonlatex condom: results from a randomized controlled clinical trial.Perspect. Sex Reprod. Health. 2003; 35: 79-86
- Testing guidance for male condoms made from new material.FDA, Washington (DC)1995
- Standardized protocols for condom breakage and slippage trials: a proposal.Am. J. Public Health. 1994; 84: 1897-1900
- Semen quantification utilizing P30 antigen.in: Proceedings: Inter-American congress of forensic sciences. 1982
- Chapman and Hall, New York1984: 50-51 Analysis of survival data.
- Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples.Br. J. Cancer. 1977; 35: 1-39
Accepted: May 22, 2004
Received in revised form: May 20, 2004
Received: March 17, 2004
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.