Coitus
Conditions
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.
Interventions
OTHERIntimate Health Gel
Intimate Health Gel
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
United States
Outcome results
None listed