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

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ClinicalTrials.gov Identifier: NCT00778934
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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
Coitus Other: Intimate Health Gel Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
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 : December 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
Intimate Health Gel
Other: Intimate Health Gel
Intimate Health Gel
Other Name: Not marketed yet




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 [ Time Frame: 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. [ Time Frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs) ]


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

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

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 Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011