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A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779025
First Posted: October 24, 2008
Last Update Posted: October 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
Results First Submitted: March 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Coitus
Interventions: Device: PD-F-5254
Device: 10855-096

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Overall Study (ITT) The group evaluated was based on intention to treat (ITT).

Baseline Measures
   Overall Study (ITT) 
Overall Participants Analyzed 
[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
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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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information