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A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

NCT ID: NCT00779025

Last Updated: 2011-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-02-29

Brief Summary

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The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Detailed Description

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Study to evaluate the safety of Class II personal lubricant devices.

Conditions

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Coitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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YOURS and MINE

Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)

Group Type EXPERIMENTAL

PD-F-5254

Intervention Type DEVICE

Female Personal Lubricant (MINE)

10855-096

Intervention Type DEVICE

Male Personal Lubricant (YOURS)

MINE Alone

Female Personal Lubricant (PD-F-5254)

Group Type ACTIVE_COMPARATOR

PD-F-5254

Intervention Type DEVICE

Female Personal Lubricant (MINE)

Interventions

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PD-F-5254

Female Personal Lubricant (MINE)

Intervention Type DEVICE

10855-096

Male Personal Lubricant (YOURS)

Intervention Type DEVICE

Other Intervention Names

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K-Y K-Y

Eligibility Criteria

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Inclusion Criteria

* Normal, healthy males and females \>18 years of age
* In committed heterosexual relationship for \>6months
* 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

ALL

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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Concentrics Center for Research

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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CA-P-6020-1

Identifier Type: -

Identifier Source: org_study_id