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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.
Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom.
The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyisoprene condoms lubricated with a silicone lubricant | Experimental | polyisoprene condoms lubricated with a silicone lubricant |
|
| commercial latex condoms with a silicone lubricant | Active Comparator | commercial latex condoms with a silicone lubricant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone Lubricated Synthetic polyisoprine condom | Device | Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 -7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 - 7 weeks |
| Clinical Complete Slippage |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essential Access | Recruiting | Berkeley | California | 94710 | United States |
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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
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Each product will be labeled with a randomly generated code
| Silicone Lubricated Natural Rubber Latex Condom | Device | Natural rubber latex condoms are made from natural rubber |
|
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
| 5-7 weeks |
| Essential Access | Recruiting | Los Angeles | California | 90010-2648 | United States |
|