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To evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subject | Experimental | Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trojan "Simply Pleasure" Personal Lubricant | Device | silicone base without sensate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Observed Local Erythema Based on 5 Point Scale | Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema | 2 weeks |
| Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale | Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Laboratories, LLC | Piscataway | New Jersey | 08854 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subject | Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subject | Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Observed Local Erythema Based on 5 Point Scale | Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema | Posted | Count of Participants | Participants | 2 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Subject | Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annahita Ghassemi | Church & Dwight Co., Inc | 6098061200 | annahita.ghassemi@churchdwight.com |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| D004487 | Edema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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|
|
| Primary | Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale | Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema | Posted | Count of Participants | Participants | 2 weeks |
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| 0 |
| 33 |
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| 33 |
Master service agreement and confidentiality agreement in place
| D013568 | Pathological Conditions, Signs and Symptoms |