This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.
Between the ages of 18 and 45 (inclusive)
Willing and able to give written or electronic informed consent
Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
Be sexually active (defined as averaging one vaginal coital act per week)
Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
Female partner self-reported as pregnant
Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
Unable to follow instructions or strictly adhere to the visit schedule
Crossover
Silicone Lubricated Synthetic polyisoprine condom
DeviceSynthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
Silicone Lubricated Natural Rubber Latex Condom
DeviceNatural rubber latex condoms are made from natural rubber
Total Clinical Failure
The total clinical failure rate is defined as the number of condoms that broke or slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
Clinical Breakage
The clinical breakage rate is defined as the number of condoms that broke during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
Clinical Complete Slippage
The clinical complete slippage rate is defined as the number of condoms that slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse
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