Status:
COMPLETED
Safety Study for an All-in-One Body and Personal Lubricant
Lead Sponsor:
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Conditions:
Lubricating Agents
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.
Detailed Description
This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will...
Eligibility Criteria
Inclusion
- Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
- Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
- Able to read and understand English
- Voluntarily signs an Informed Consent document after the trial has been explained
- Willing to follow all study procedures, including birth control requirements
Exclusion
- Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
- Participation as a research subject in a different trial within timelines dictated by protocol
- Participants with relationships or employment outside protocol-defined parameters
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01189617
Start Date
June 1 2010
End Date
August 1 2010
Last Update
February 27 2017
Active Locations (1)
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1
Concentrics Research
Indianapolis, Indiana, United States, 46240