A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
1 other identifier
interventional
82
1 country
1
Brief Summary
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 23, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedResults Posted
Study results publicly available
May 5, 2011
CompletedOctober 7, 2011
October 1, 2011
1 month
October 23, 2008
March 30, 2011
October 4, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Number of Sensations Experienced by Male Subjects - Overall
1 Week
Number of Sensations Experienced by Female Subjects - Overall
1 Week
Study Arms (2)
MINE Alone
ACTIVE COMPARATORFemale Personal Lubricant (PD-F-5254)
YOURS and MINE
EXPERIMENTALMale Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Interventions
Eligibility Criteria
You may qualify if:
- Normal, healthy males and females \>18 years of age
- In committed heterosexual relationship for \>6months
- On acceptable method of birth control
You may not qualify if:
- Pregnant or breastfeeding
- Allergy to product ingredients
- Irritation or infection in genital area
- Unstable or uncontrolled medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Concentrics Center for Research
Indianapolis, Indiana, 46240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
- Organization
- Johnson & Johnson Consumer and Personal Products Worldwide
Study Officials
- STUDY DIRECTOR
Rita Wanser
J&J CPPW
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2008
First Posted
October 24, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
October 7, 2011
Results First Posted
May 5, 2011
Record last verified: 2011-10