American Journal of Epidemiology Advance Access originally published online on April 9, 2007
American Journal of Epidemiology 2007 166(1):88-96; doi:10.1093/aje/kwm046
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ORIGINAL CONTRIBUTIONS |
Efficacy of the Male Latex Condom and of the Female Polyurethane Condom as Barriers to Semen during Intercourse: A Randomized Clinical Trial
1 Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA
2 Department of Obstetrics and Gynecology, School of Medicine, University of Alabama at Birmingham, Birmingham, AL
3 Department of Maternal and Child Health, School of Public Health, University of Alabama at Birmingham, Birmingham, AL
4 Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL
5 HIV Vaccine Trials Network, Seattle, WA
Correspondence to Dr. Maurizio Macaluso, 4770 Buford Highway, NE, Mail Stop K-34, Atlanta, GA 30341-3717 (e-mail: mmacaluso{at}cdc.gov).
Received for publication August 8, 2006. Accepted for publication January 3, 2007.
In this 2000–2001 study, the authors compared the effectiveness of the male latex condom and the female polyurethane condom by assessing frequency and types of mechanical failure and by evaluating semen exposure during use. Eligible women from Birmingham, Alabama, were randomly assigned to begin the study with 10 male condoms and then switch to 10 female condoms (n = 55), or vice versa (n = 53), and were trained to use both types. Data collection included questionnaires for each condom use and measurement of prostate-specific antigen in specimens of vaginal fluid taken before and after intercourse. Participants returned 700 male condoms and 678 female condoms, and they reported mechanical problems for 9% and 34%, respectively. Moderate-high postcoital prostate-specific antigen levels (
22 ng/ml) were detected in 3.5% of male condom uses and 4.5% of female condom uses (difference = 1%, 95% confidence interval: –1.6, 3.7). Moderate-high prostate-specific antigen values (22 ng/ml) were more frequent with mechanical problems (male condom, 9.6%; female condom, 9.4%) but less frequent with other problems (3.0% and 0.9%) or correct use with no problems (2.7% and 2.5%). This study indicates that although mechanical problems are more common with the female condom than with the male condom, these devices may involve a similar risk of semen exposure. Objectively assessed semen exposure is associated with self-reported mechanical problems.
clinical trials; condoms; condoms, female; contraception, barrier; prostate-specific antigen; treatment outcome
Abbreviations: PSA, prostate-specific antigen; STD, sexually transmitted disease
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