Evaluation of Polyurethane Male Condoms

The clinical study will compare two lubricated polyurethane male condoms of different thickness and different sizes with a marketed lubricated control male condom made of natural rubber latex. Couples entering the study will be expected to use 5 of each type of the 3 condoms in a randomised order. The identity of the condoms will be masked to both the couples and the investigators. The aim will be to recruit 300 heterosexual with the intent of achieving a minimum 1,000 uses of each condom type. Couples will report condom use events using a condom report form. The primary information collected will relate to condom breakage and slippage of the penis during use. The total clinical failure rates (breakage and slippage) of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.