Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial.
BACKGROUND
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.
Research Division, California Family Health Council, Los Angeles, USA. walsht@cfhc.org
Terri L
TL
Walsh
Ron G
RG
Frezieres
Karen
K
Peacock
Anita L
AL
Nelson
Virginia A
VA
Clark
Leslie
L
Bernstein
D000328:Adult; D003075:Coitus; D017280:Condoms / Q000592:standards* / Q000706:statistics & numerical data*; D003258:Consumer Behavior; D003268:Contraception Behavior / Q000706:statistics & numerical data; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007840:Latex; D008297:Male; D008875:Middle Aged; D011140:Polyurethanes / Q000009:adverse effects*; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States
D007840:Latex; D011140:Polyurethanes