Advancing Sexual and Reproductive Health and Rights
 
Perspectives on Sexual and Reproductive Health
Volume 35, Number 2, March/April 2003

Evaluation of the Efficacy of a Nonlatex Condom: Results from a Randomized, Controlled Clinical Trial

By Terri L. Walsh, Ron G. Frezieres, Karen Peacock, Anita L. Nelson, Virginia A. Clark and Leslie Bernstein

CONTEXT: To reduce unintended pregnancy and HIV infection, it is critical to develop reliable male condoms that will attract consumers who reject conventional latex condoms.

METHODS: In a prospective clinical trial conducted in 1998-2000, 830 monogamous couples were randomized in equal numbers to use either a nonlatex condom or a commercial natural latex condom for six months as their only method of birth control. Couples completed detailed reports for the first five condom uses and recorded intercourse and condom use in coital diaries. Pregnancy rates associated with typical and consistent condom use were calculated using life-table analysis. Rates of clinical failure (condom breakage or slippage) were determined for the first five condom uses.

RESULTS: During the first five uses, the nonlatex condom had a higher frequency of breakage or slippage during intercourse or withdrawal (4.0%) than latex condoms (1.3%); the breakage rate for the nonlatex condom was about eight times that of latex condoms. The six-cycle typical-use pregnancy rate did not differ significantly between users of nonlatex (10.8%) and latex condoms (6.4%). The six-cycle consistent-use pregnancy rate was higher for nonlatex condom users than for latex condom users (4.9% vs. 1.0%).

CONCLUSIONS: The data present strong indirect support for public health messages that promote the use of latex condoms and, for individuals who cannot or are unwilling to use latex condoms, the use of nonlatex condoms for prevention of pregnancy and disease.

Perspectives on Sexual and Reproductive Health, 2003, 35(2):79-86

DOI:10.1363/3507903







 

 
 

Terri L. Walsh is director of clinical trials and evaluation, Ron G. Frezieres is director and Karen Peacock is project director, all at the Research Division, California Family Health Council, Los Angeles. Anita L. Nelson is professor, Department of Obstetrics and Gynecology and the Research and Education Institute, Harbor-UCLA Medical Center, Torrance, CA. Virginia A. Clark is professor emerita, School of Public Health, University of California, Los Angeles. Leslie Bernstein is professor, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles.