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In-Home Use Study to Evaluate Use of an Intimate Health Product in Females

Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
Overall Status
Completed
CT.gov ID
NCT00778934
Collaborator
(none)
79
Enrollment
2
Locations
1
Arm
4
Duration (Months)
39.5
Patients Per Site
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

Condition or Disease Intervention/Treatment Phase
  • Other: Intimate Health Gel
 N/A

Detailed Description

Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Official Title:
A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Intimate Health Gel

Other: Intimate Health Gel
Intimate Health Gel
Other Names:
  • Not marketed yet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses [End of study (3 weeks after baseline visit)]

    Secondary Outcome Measures

    1. Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. [throughout duration of the study (+ 30 days for spontaneously reported SAEs)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Normal, healthy females >18 years of age

    • In committed heterosexual relationship for >6months

    • Of adequate sexual functioning

    • 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

    Locations

    Site City State Country Postal Code
    1 Center of Marital and Sexual Health of South Florida West Palm Beach Florida United States 33401
    2 Center for Marital and Sexual Health, Inc. Beachwood Ohio United States 44122

    Sponsors and Collaborators

    • Johnson & Johnson Consumer and Personal Products Worldwide

    Investigators

    • Study Director: Rita Wanser, J&J CPPW

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnson & Johnson Consumer and Personal Products Worldwide
    ClinicalTrials.gov Identifier:
    NCT00778934
    Other Study ID Numbers:
    • CA-P-5739-1
    First Posted:
    Oct 24, 2008
    Last Update Posted:
    Oct 6, 2011
    Last Verified:
    Oct 1, 2011

    Study Results

    No Results Posted as of Oct 6, 2011