Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Match Research | OTHER |
| Essential Access Health | OTHER |
| Sigma3 Services SARL | UNKNOWN |
Not provided
Not provided
Not provided
Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.
A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom. Each couple will be asked to use five synthetic nitrile condoms, and five latex control male condoms 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 two follow-up visits conducted after using each set of five condoms. The trial will enrol up to 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthetic Nitrile Condom (61mm) | Experimental | 61mm width synthetic Nitrile condoms |
|
| Control Latex Condom | Active Comparator | 61mm width Natural Rubber Latex condoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Nitrile Condom (61mm) | Device | 61mm 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 | 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 i.e Comfort in use, ease of fitting and removal, like or dislike of product attributes, adequacy and feel of lubrication. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mags Beksinska, PhD | MRU (MatCH Research Unit) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essential Access Health | Berkeley | California | 94710 | United States | ||
| Essential Access Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.
Not provided
Not provided
Each product will be labeled with a randomly generated code.
| Control Latex Condom | Device | 61mm width Natural Rubber Latex Condom |
|
Questionnaires obtained after participants complete 5 condom uses of each condom type cover multiple acceptability factors. For these acceptability measures, Likert scores ranging from 1 (lowest) to 5 (highest) will be compared across condom types. |
| 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 | 4000 | South Africa |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |