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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014