A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-Use Conditions - Full Text View

Sponsored by:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00779025

Purpose

The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Condition	Intervention
Coitus	Device: Female and Male Personal Lubricants Device: Female Personal Lubricant

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-Use Conditions

Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:

To assess the safety of personal lubricant products via clinical and subjective assessments [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Female and Male Personal Lubricants	Device: Female and Male Personal Lubricants Female and Male Personal Lubricants
2: Active Comparator Female Personal Lubricant	Device: Female Personal Lubricant Female Personal Lubricant

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779025

Locations

United States, Indiana
Concentrics Center for Research
Indianapolis, Indiana, United States, 46240

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Rita Wanser

J&J CPPW

More Information

Responsible Party:	J&J CPPW ( Joyce Hauze/Senior Project Manager )
Study ID Numbers:	CA-P-6020-1
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779025
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 14, 2009