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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00778934
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 evaluate the effects of an intimate health product on sexual experience in females.


Condition Intervention
Coitus
 Other: Intimate Health Gel

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females

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

Primary Outcome Measures:
  • To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses [ Time Frame: End of study (3 weeks after baseline visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs) ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intimate Health Gel
 Other: Intimate Health Gel
Intimate Health Gel
Other Name: Not marketed yet

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778934

Locations
United States, Florida
Center of Marital and Sexual Health of South Florida
West Palm Beach, Florida, United States, 33401
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00778934     History of Changes
Other Study ID Numbers: CA-P-5739-1
Study First Received: October 23, 2008
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013