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

Not Applicable

Completed

• Conditions: Coitus
• Interventions: Device: PD-F-5254; Device: 10855-096

• Registration Number: NCT00779025
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Results First Submitted: 2011-03-30
• Results First Submitted QC: 2011-05-02
• Results First Posted: 2011-05-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MINE Alone	PD-F-5254	Female Personal Lubricant (PD-F-5254)
YOURS and MINE	10855-096	Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
YOURS and MINE	PD-F-5254	Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)

Primary Outcome Measures

Name	Time	Method
Number of Participants Showing Change From Baseline in Irritation Scores	1 week	Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions

Secondary Outcome Measures

Name	Time	Method
Number of Sensations Experienced by Male Subjects - Overall	1 Week	Number of sensations experienced by male subjects, based on two applications of the investigational product.
Number of Sensations Experienced by Female Subjects - Overall	1 Week	Number of sensations experienced by female subjects, based on two applications of the product for each subject.

Trial Locations

Locations (1)

Concentrics Center for Research; 🇺🇸 Indianapolis, Indiana, United States