A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
This study has been completed.
Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00779025
First received: October 23, 2008
Last updated: October 4, 2011
Last verified: October 2011
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Results First Received: March 30, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label |
| Condition: |
Coitus |
| Interventions: |
Device: PD-F-5254 Device: 10855-096 |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Overall Study (ITT) | The group evaluated was based on intention to treat (ITT). |
Participant Flow: Overall Study
| Overall Study (ITT) | |
|---|---|
| STARTED | 82 |
| COMPLETED | 81 |
| NOT COMPLETED | 1 |
| Withdrawal by Subject | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Overall Study (ITT) | The group evaluated was based on intention to treat (ITT). |
Baseline Measures
| Overall Study (ITT) | |
|---|---|
|
Number of Participants
[units: participants] |
82 |
|
Age, Customized
[units: Years] Mean ± Standard Deviation |
|
| Male | 42.3 ± 14.5 |
| Female | 40.0 ± 13.3 |
|
Gender
[units: participants] |
|
| Female | 41 |
| Male | 41 |
|
Region of Enrollment
[units: participants] |
|
| United States | 82 |
Outcome Measures
| 1. Primary: | Number of Participants Showing Change From Baseline in Irritation Scores [ Time Frame: 1 week ] |
| 2. Secondary: | Number of Sensations Experienced by Male Subjects - Overall [ Time Frame: 1 Week ] |
| 3. Secondary: | Number of Sensations Experienced by Female Subjects - Overall [ Time Frame: 1 Week ] |