Status:
COMPLETED
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Coitus
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Normal, healthy males and females \>18 years of age
- In committed heterosexual relationship for \>6months
- On acceptable method of birth control
Exclusion
- Pregnant or breastfeeding
- Allergy to product ingredients
- Irritation or infection in genital area
- Unstable or uncontrolled medical condition
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00779025
Start Date
January 1 2008
End Date
February 1 2008
Last Update
October 7 2011
Active Locations (1)
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1
Concentrics Center for Research
Indianapolis, Indiana, United States, 46240