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

This study has been completed.
Sponsor:
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
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
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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)  
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
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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


  More Information