SAFETY, FUNCTIONALITY AND ACCEPTABILITY OF A PROTOTYPE POLYURETHANE CONDOM

Male condoms made from synthetic materials offer an alternative to lat ex condoms that may be more acceptable to users, thereby potentially r esulting in more protected acts of intercourse. A prospective, noncomp arative clinical study was conducted to evaluate the safety of using c ertain polyurethane materials to make condoms. Fifty-one healthy, cont racepting, mutually monogamous couples were recruited between June 30 and November 24, 1993 to use a prototype roll-on polyurethane condom d eveloped by Family Health International. Couples were to use the condo ms for 10 consecutive acts of vaginal intercourse over a 4-week period . Baseline and postexposure genital examinations, including colposcopy for female participants, were performed. Fifty couples completed the study requirements and 517 acts of intercourse occurred using the cond oms. Two adverse events were reported: irritation of introitus in a fe male participant and a small irritated erythematous lesion on a male p articipant's penis. Neither event was considered to be serious and bot h were resolved without treatment. Breakage and slippage rates were si milar to those reported for latex condoms. These results suggest that polyurethane condoms represent a safe, functional and acceptable alter native to latex condoms.