About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Silicone Lubricated Synthetic polyisoprine condom
- Silicone Lubricated Natural Rubber Latex Condom