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The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
Study to evaluate the safety of Class II personal lubricant devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINE Alone | Active Comparator | Female Personal Lubricant (PD-F-5254) |
|
| YOURS and MINE | Experimental | Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-F-5254 | Device | Female Personal Lubricant (MINE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Showing Change From Baseline in Irritation Scores | Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sensations Experienced by Male Subjects - Overall | Number of sensations experienced by male subjects, based on two applications of the investigational product. | 1 Week |
| Number of Sensations Experienced by Female Subjects - Overall |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Wanser | J&J CPPW | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concentrics Center for Research | Indianapolis | Indiana | 46240 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study (ITT) | The group evaluated was based on intention to treat (ITT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study (ITT) | The group evaluated was based on intention to treat (ITT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 Showing Change From Baseline in Irritation Scores | Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions | Analysis was per Intention to Treat (ITT) | Posted | Number | Participants | 1 week |
|
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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 | Overall Study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations | Johnson & Johnson Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| 10855-096 | Device | Male Personal Lubricant (YOURS) |
|
|
Number of sensations experienced by female subjects, based on two applications of the product for each subject.
| 1 Week |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Sensations Experienced by Male Subjects - Overall | Number of sensations experienced by male subjects, based on two applications of the investigational product. | Posted | Number | Sensations | 1 Week | Applications | Participants |
|
|
|
| Secondary | Number of Sensations Experienced by Female Subjects - Overall | Number of sensations experienced by female subjects, based on two applications of the product for each subject. | Intention to Treat | Posted | Number | Sensations | 1 Week | Applications | Participants |
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
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| Stinging |
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| Tingling |
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| Warming |
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| Stinging |
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| Tingling |
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| Warming |
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