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To evaluate the safety of Miami w/ frag Personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miami w/ frag Personal lubricant | Experimental | Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miami w/ frag Personal lubricant | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Observed Local Erythema | Number of participants with observed erythema by OB/GYN examination. | 14 Days |
| Number of Participants With Observed Local Edema | Number of participants with observed edema by OB/GYN examination. | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Laboratories | Piscataway | New Jersey | 08854 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Lubricant Miami w/ Frag Personal Lubricant | Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Lubricant Miami w/ Frag Personal Lubricant | Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Participants With Observed Local Erythema | Number of participants with observed erythema by OB/GYN examination. | female only | Posted | Number | participants | 14 Days |
|
|
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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 | Miami w/ Frag Personal Lubricant | Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks. |
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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 |
|
|
| Primary | Number of Participants With Observed Local Edema | Number of participants with observed edema by OB/GYN examination. | female only | Posted | Number | participants | 14 Days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
Master service agreement and confidentiality agreement in place
| D013568 | Pathological Conditions, Signs and Symptoms |