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Fam Plann Perspect. 1999 Mar-Apr;31(2):81-7.

Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.

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  • 1Research Division of the California Family Health Council, Los Angeles, USA.

Abstract

CONTEXT:

Condoms made of latex are not comfortable or appropriate for all consumers. Polyurethane condoms may provide a needed alternative.

METHODS:

In a double-masked study, 805 monogamous couples were randomized to use either the polyurethane condom or the latex condom for six months. Couples recorded the frequency of intercourse, of condom use and of breakage and slippage throughout the trial in coital diaries and in detailed reports on the first five uses. Breakage and slippage rates were determined, and typical-use and consistent-use pregnancy rates were calculated using life-table analysis, adjusted for use of emergency contraception.

RESULTS:

The six-month pregnancy rate during typical use (adjusted for use of emergency contraception) was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over six completed menstrual cycles--2.4% for the polyurethane condom and 1.1% for the latex condom--did not differ significantly. Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for the latex condom. In general, male participants were more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were users of polyurethane.

CONCLUSIONS:

Although polyurethane and latex condoms provide equivalent levels of contraceptive protection, the polyurethane condom's higher frequency of breakage and slippage suggests that this condom may confer less protection from sexually transmitted infections than does the latex condom.

PIP:

Latex condoms are neither comfortable nor appropriate for all condom users. In a double-blinded study, 805 monogamous heterosexual couples aged 18-45 years were randomized to use either a polyurethane condom or the Ramses Sensitol latex condom for 6 months. The polyurethane condom had specifications similar to those of the commercially available Avanti condom. While both condoms are 180 mm long, with an open end diameter of 33 mm, when laid flat, the polyurethane and latex condoms are 64 and 52 mm wide, respectively. Recruited from Los Angeles, California, study participants were of mean age 27 years; 66% non-Hispanic Whites, 16% Hispanic, 6% Black, and 6% Asian; and with an average of 15 years education. Approximately 75% of the men were circumcised, and according to participants' measurements, the erect penis averaged 131 mm in midshaft circumference and 159 mm in length. 89% were using condoms as their contraceptive method at the start of the study. The 6-month pregnancy rate during typical use, adjusted for the use of emergency contraception, was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over 6 completed menstrual cycles were 2.4% for the polyurethane condom and 1.1% for the latex condom. Clinical failure rates, including breakage and slippage occurring during either intercourse or withdrawal were 8.5% for the polyurethane condom and 1.6% for the latex condom. Male participants were generally more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were polyurethane condom users.

PMID:
10224546
[PubMed - indexed for MEDLINE]
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