Evaluation of Polyurethane Male Condoms

A Randomized, Masked, 3-way Cross-over, Multi-center, Clinical Investigation to Evaluate Two Polyurethane Condoms in Healthy Monogamous Couples Compared With a Standard Latex Condom

The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates 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.

Evaluation of Polyurethane Male Condoms

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