This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.
Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly determined) to use over a two week period, followed by 4 condoms of the other type to be used over the next two week period. The number of clinical failures (either condom breaks or completely slips off the penis) for each condom type will be compared to determine whether the test condom is non-inferior to the control condom. The study plan is based on International Standards Organization (ISO) guidance document ISO 29943-1 with the action standard set by synthetic condom standard ISO 23409.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
Synthetic Male Condom
Latex Male Condom
Essential Access Health
Berkeley, California, United States
Essential Access Health
Los Angeles, California, United States
Total Clinical Failure Rate
The number of condoms that broke or slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Clinical Breakage Rate
The number of condoms that broke during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
Clinical Complete Slippage Rate
The number of condoms that slipped completely off the penis during intercourse or withdrawal divided by the number of condoms used for vaginal intercourse.
Time frame: Throughout the study. Each participating couple will engage in 8 acts over a 4 week period.
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