Safety, functionality and acceptability of a prototype polyurethane condom

Male condoms made from synthetic materials offer an alternative to latexcondoms that may be more acceptable to users, thereby potentially resultingin more protected acts of intercourse. A prospective, noncomparativeclinical study was conducted to evaluate the safety of using certainpolyurethane materials to make condoms. Fifty-one healthy, contracepting,mutually monogamous couples were recruited between June 30 and November 24,1993 to use a prototype roll-on polyurethane condom developed by FamilyHealth International. Couples were to use the condoms for 10 consecutiveacts of vaginal intercourse over a 4-week period. Baseline and postexposuregenital examinations, including colposcopy for female participants, wereperformed. Fifty couples completed the study requirements and 517 acts ofintercourse occurred using the condoms. Two adverse events were reported:irritation of introitus in a female participant and a small irritatederythematous lesion on a male participants penis. Neither event wasconsidered to be serious and both were resolved without treatment. Breakageand slippage rates were similar to those reported for latex condoms. Theseresults suggest that polyurethane condoms represent a safe, functional andacceptable alternative to latex condoms.