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This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Vaginal Ring | Experimental | Placebo vaginal ring with condom use |
|
| Condom | Other | Male condoms during vaginal intercourse in presence and absence of the vaginal ring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Vaginal Ring | Combination Product | a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant. |
| Measure | Description | Time Frame |
|---|---|---|
| Total clinical failure rate (N slipped or broken/N total) off the penis or broke during intercourse or withdrawal, divided by the number of condoms used during intercourse. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Frezieres | California Family Health Council | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Family Health Council | Berkeley | California | 94710 | United States | ||
| California Family Health Council |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017280 | Condoms |
| ID | Term |
|---|---|
| D003275 | Contraceptive Devices, Male |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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IPM 029 is an open-label, randomized, two-period, crossover non-inferiority trial conducted at two research centers in the U.S. to assess condom functionality during vaginal intercourse in healthy, monogamous heterosexual, sexually active couples.
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|
| Condom | Device | Male condom |
|
| Los Angeles |
| California |
| 90010 |
| United States |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |