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

NCT ID: NCT00778934

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Coitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Intimate Health Gel

Group Type EXPERIMENTAL

Intimate Health Gel

Intervention Type OTHER

Intimate Health Gel

Interventions

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Intimate Health Gel

Intimate Health Gel

Intervention Type OTHER

Other Intervention Names

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Not marketed yet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita Wanser

Role: STUDY_DIRECTOR

J&J CPPW

Locations

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Center of Marital and Sexual Health of South Florida

West Palm Beach, Florida, United States

Site Status

Center for Marital and Sexual Health, Inc.

Beachwood, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CA-P-5739-1

Identifier Type: -

Identifier Source: org_study_id