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

October 4, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide

A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Center of Marital and Sexual Health of South Florida
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Center for Marital and Sexual Health, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Intimate Health Gel
Other: Intimate Health Gel
Intimate Health Gel
Other Names:
  • Not marketed yet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
End of study (3 weeks after baseline visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
throughout duration of the study (+ 30 days for spontaneously reported SAEs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (ESTIMATE)

October 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • CA-P-5739-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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