In-Home Use Study to Evaluate Use of an Intimate Health Product in Females
Not Applicable
Completed
- Conditions
- Coitus
- Interventions
- Other: Intimate Health Gel
- Registration Number
- NCT00778934
- Brief Summary
The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.
- Detailed Description
Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 79
Inclusion Criteria
- Normal, healthy females >18 years of age
- In committed heterosexual relationship for >6months
- Of adequate sexual functioning
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Intimate Health Gel Intimate Health Gel
- Primary Outcome Measures
Name Time Method To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses End of study (3 weeks after baseline visit)
- Secondary Outcome Measures
Name Time Method Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product. throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Trial Locations
- Locations (2)
Center of Marital and Sexual Health of South Florida
🇺🇸West Palm Beach, Florida, United States
Center for Marital and Sexual Health, Inc.
🇺🇸Beachwood, Ohio, United States