Results

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

Terri L. Walsh, MPH, Ron G. Frezieres, MSPH, Karen Peacock, MA, Anita L. Nelson, MD, Virginia A. Clark, PHD, Leslie Bernstein, PHD. Perspectives on Sexual and Reproductive Health 2003 35(2): 79-86

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 condoms 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 the latex condom (1.3%); the breakage rate for the nonlatex condom was about eight times that of the 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 non-latex users than for latex condom users (4.9% vs 1.0%).

Conclusions: The data present strong indirect support for the 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.

Return to Study Results