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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00778934
First Posted: October 24, 2008
Last Update Posted: October 6, 2011
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.
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
  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: 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

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) ]

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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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): 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

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00778934     History of Changes
Other Study ID Numbers: CA-P-5739-1
First Submitted: October 23, 2008
First Posted: October 24, 2008
Last Update Posted: October 6, 2011
Last Verified: October 2011