In-Home Use Study to Evaluate Use of an Intimate Health Product in Females

Johnson & Johnson Consumer and Personal Products Worldwide79 enrolled

Overview

The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.

Study Type

INTERVENTIONAL

Allocation

Masking

SINGLE

Enrollment

Conditions

Coitus

Interventions

Intimate Health GelOTHER

Intimate Health Gel

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses

Time frame: End of study (3 weeks after baseline visit)

Secondary Outcomes

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.

Time frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.