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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:
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
History of Changes
  Purpose

The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.


Condition Intervention
Coitus
 Device: PD-F-5254
Device: 10855-096

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Number of Participants Showing Change From Baseline in Irritation Scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Number of Sensations Experienced by Male Subjects - Overall [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    Number of sensations experienced by male subjects, based on two applications of the investigational product.

  • Number of Sensations Experienced by Female Subjects - Overall [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    Number of sensations experienced by female subjects, based on two applications of the product for each subject.


Enrollment: 82
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00779025     History of Changes
Other Study ID Numbers: CA-P-6020-1
Study First Received: October 23, 2008
Results First Received: March 30, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013