A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Coitus Clinical Trial

Official title:

A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779025
• Other study ID #: CA-P-6020-1
• Status: Completed
• Phase: N/A
• First received: October 23, 2008
• Last updated: October 4, 2011
• Start date: January 2008
• Est. completion date: February 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 study in couples and to evaluate the safety of personal lubricant products.

Description:

Study to evaluate the safety of Class II personal lubricant devices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal, healthy males and females >18 years of age

• In committed heterosexual relationship for >6months

• 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coitus

Intervention

Device:
• PD-F-5254
Female Personal Lubricant (MINE)
• 10855-096
Male Personal Lubricant (YOURS)

Locations

Country	Name	City	State
United States	Concentrics Center for Research	Indianapolis	Indiana

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	Number of Participants Showing Change From Baseline in Irritation Scores	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	1 week	No
Secondary	Number of Sensations Experienced by Male Subjects - Overall	Number of sensations experienced by male subjects, based on two applications of the investigational product.	1 Week	No
Secondary	Number of Sensations Experienced by Female Subjects - Overall	Number of sensations experienced by female subjects, based on two applications of the product for each subject.	1 Week	No