Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial
Frezieres, R.G.; Walsh, T.L.; Nelson, A.L.; Clark, V.A.; Coulson, A.H.
Family Planning Perspectives 31(2): 81-87
1999
ISSN/ISBN: 0014-7354 PMID: 10224546 DOI: 10.2307/2991645Document Number: 282013
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.