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

Coitus Clinical Trial

Official title:

A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778934
• Other study ID #: CA-P-5739-1
• Status: Completed
• Phase: N/A
• First received: October 23, 2008
• Last updated: October 4, 2011
• Start date: December 2007
• Est. completion date: April 2008

Study information

• Verified date: October 2011
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Coitus

Intervention

Other:
• Intimate Health Gel
Intimate Health Gel

Locations

Country	Name	City	State
United States	Center for Marital and Sexual Health, Inc.	Beachwood	Ohio
United States	Center of Marital and Sexual Health of South Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No