A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
- Conditions
- Coitus
- Registration Number
- NCT00779025
- 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
- Normal, healthy males and females >18 years of age
- In committed heterosexual relationship for >6months
- On acceptable method of birth control
- 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
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.
Related Research Topics
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Trial Locations
- Locations (1)
Concentrics Center for Research
🇺🇸Indianapolis, Indiana, United States
Concentrics Center for Research🇺🇸Indianapolis, Indiana, United States