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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| Essential Access Health | OTHER |
| Sigma3 Services SARL | UNKNOWN |
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This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.
A sequential randomised 3-period cross-over trial comparing five uses of two synthetic nitrile male condoms of different sizes with a control latex male condom. Each couple will be asked to use five synthetic nitrile condoms (53 mm width), five synthetic nitrile condoms (56 mm width) and five latex male condoms (53 mm width) in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of three follow-up visits conducted after using each set of five condoms. The trial will enrol 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthetic Nitrile Condoms (53mm) | Experimental | 53mm width synthetic nitrile condoms |
|
| Synthetic Nitrile Condoms (56mm) | Experimental | 56mm width synthetic nitrile condoms |
|
| Control Latex Condom | Active Comparator | Commercial natural rubber latex condom |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Nitrile Condoms (53mm) | Device | 53mm width synthetic nitrile condoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical breakage | Clinical breakage is defined as breakage or tearing during sexual intercourse or during withdrawal of the male condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of male condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of male condoms used during vaginal intercourse. | 3 - 5 months |
| Clinical slippage | Clinical slippage is defined as a condom slipping completely off the penis during sexual intercourse or during withdrawal from the vagina. The clinical slippage rate is calculated by dividing the number of male condoms that slipped by the number of male condoms used during vaginal intercourse. | 3 - 5 months |
| Clinical failure | A Clinical failure is defined as a clinical breakage or a clinical slippage. The clinical failure rate is calculated by dividing the number of male condoms with a clinical failure by the number of male condoms used during vaginal intercourse. | 3 - 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Genital discomfort | Rates of genital discomfort reported to have occurred during or immediately after condom use. Genital adverse events will be classified by relatedness, expectedness and severity. | 3 - 5 months |
| Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mags Beksinska, PhD | MatCH Research Unit (MRU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essential Access Health | Berkeley | California | 94710 | United States | ||
| Essential Access Health |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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A sequential randomised 3-period cross-over trial comparing the functional performance of two synthetic male condoms against a control latex male condom.
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Each product will be labeled with a randomly generated code.
| Synthetic Nitrile Condoms (56mm) | Device | 56mm width synthetic nitrile condoms |
|
| Control Latex Condom | Device | Commercial natural rubber latex condom |
|
Frequency of key acceptability outcome measures will be calculated and include: comfort in use; ease of insertion and removal; like or dislike of product attributes; adequacy and feel of lubrication and sensitivity and stimulation.
| 3 - 5 months |
| Non-Clinical breakage | Defined as breakage noticed before sexual intercourse or occurring after withdrawal of the male condom from the vagina. Non-clinical breakage is breakage with no potential adverse clinical consequences. The non-clinical breakage rate is calculated by dividing the number of male condoms reported to have broken before sexual intercourse or after withdrawal by the number of male condom packages opened. | 3 - 5 months |
| Non-Clinical slippage | Defined as slippage along the shaft of the penis during sexual intercourse (but not completely off the penis). Non-clinical slippage is slippage with no potential adverse clinical consequences. The non-clinical slippage rate is calculated by dividing the number of male condoms reported to have partially slipped during sexual intercourse by the number of male condoms used during vaginal intercourse. | 3 - 5 months |
| Los Angeles |
| California |
| 90010 |
| United States |
| MRU (MatCH Research Unit) | Durban | KwaZulu-Natal | 4001 | South Africa |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |