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

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.
ClinicalTrials.gov Identifier: NCT00779025
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : May 5, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Condition or disease Intervention/treatment
Coitus Device: PD-F-5254 Device: 10855-096

Detailed Description:
Study to evaluate the safety of Class II personal lubricant devices.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
Study Start Date : January 2008
Primary Completion Date : February 2008
Study Completion Date : February 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: MINE Alone
Female Personal Lubricant (PD-F-5254)
Device: PD-F-5254
Female Personal Lubricant (MINE)
Other Name: K-Y
Experimental: YOURS and MINE
Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Device: PD-F-5254
Female Personal Lubricant (MINE)
Other Name: K-Y
Device: 10855-096
Male Personal Lubricant (YOURS)
Other Name: K-Y


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Showing Change From Baseline in Irritation Scores [ Time Frame: 1 week ]
    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


Secondary Outcome Measures :
  1. Number of Sensations Experienced by Male Subjects - Overall [ Time Frame: 1 Week ]
    Number of sensations experienced by male subjects, based on two applications of the investigational product.

  2. Number of Sensations Experienced by Female Subjects - Overall [ Time Frame: 1 Week ]
    Number of sensations experienced by female subjects, based on two applications of the product for each subject.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal, healthy males and females >18 years of age
  • In committed heterosexual relationship for >6months
  • On acceptable method of birth control

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Allergy to product ingredients
  • Irritation or infection in genital area
  • Unstable or uncontrolled medical condition
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779025


Locations
United States, Indiana
Concentrics Center for Research
Indianapolis, Indiana, United States, 46240
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Rita Wanser J&J CPPW
More Information

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00779025     History of Changes
Other Study ID Numbers: CA-P-6020-1
First Posted: October 24, 2008    Key Record Dates
Results First Posted: May 5, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011