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Safety Study for an All-in-One Body and Personal Lubricant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189617
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : January 10, 2014
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )

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.

Condition or disease Intervention/treatment Phase
Lubricating Agents Device: Formula PD-F-7619 Not Applicable

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 consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
Study Start Date : June 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Formula PD-F-7619
At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed.
Device: Formula PD-F-7619
Off-White to Beige Lotion
Other Names:
  • All-In-One Caressing Crème & Personal Lubricant
  • K-Y Touch Massage Warming 2-in-1 Personal Lubricant




Primary Outcome Measures :
  1. Number of Subjects With Irritation Score of "0" at Baseline and One Week [ Time Frame: Baseline and One Week ]
    Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189617


Locations
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United States, Indiana
Concentrics Research
Indianapolis, Indiana, United States, 46240
Sponsors and Collaborators
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Investigators
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Study Director: Sherryl Frisch Johnson & Johnson Consumer and Personal Products Worldwide
Study Director: Melissa Israel Johnson & Johnson Consumer and Personal Products Worldwide

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Responsible Party: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
ClinicalTrials.gov Identifier: NCT01189617    
Other Study ID Numbers: KOYNAP0011
First Posted: August 26, 2010    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: February 27, 2017
Last Verified: January 2017
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. ):
Personal Lubricant