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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. )

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 26, 2010
Results First Submitted Date  ICMJE April 26, 2013
Results First Posted Date  ICMJE January 10, 2014
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study for an All-in-One Body and Personal Lubricant
Official Title  ICMJE A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Lubricating Agents
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Formula PD-F-7619
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2013)
70
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189617
Other Study ID Numbers  ICMJE KOYNAP0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
Study Sponsor  ICMJE Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sherryl Frisch Johnson & Johnson Consumer and Personal Products Worldwide
Study Director: Melissa Israel Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP