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

Not Applicable
Completed
Conditions
Coitus
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.

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
Primary Outcome Measures
NameTimeMethod
Number of Participants Showing Change From Baseline in Irritation Scores1 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
NameTimeMethod
Number of Sensations Experienced by Male Subjects - Overall1 Week

Number of sensations experienced by male subjects, based on two applications of the investigational product.

Number of Sensations Experienced by Female Subjects - Overall1 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

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

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