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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. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Lubricating Agents
Intervention Device: Formula PD-F-7619
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Male Female
Hide Arm/Group Description Male Participants Female Participants
Period Title: Overall Study
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Male Female Total
Hide Arm/Group Description Male Participants Female Participants Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
Full Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
51.2  (12.8) 49.3  (12.8) 50.25  (12.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
0
   0.0%
35
 100.0%
35
  50.0%
Male
35
 100.0%
0
   0.0%
35
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
White 21 25 46
Black or African-American 13 9 22
American Indian or Alaska Native 1 0 1
Other [unknown] 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
Female Sub-Typing - Menopausal State  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Premenopausal NA [1]  18 18
Postmenopausal NA [1]  17 17
[1]
Data for this element is not available for male subjects because they do not experience menopause.
1.Primary Outcome
Title Number of Subjects With Irritation Score of "0" at Baseline and One Week
Hide Description 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.
Time Frame Baseline and One Week
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Male Female
Hide Arm/Group Description:
Male Participants
Female Participants
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Participants
Visit 1 - Baseline 35 35
Visit 2 - One Week 35 35
Time Frame 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
Adverse Event Reporting Description Subjects reported adverse events on questionnaires, and site staff recorded changes in medical status/history since study start. Itching, burning and stinging counted as adverse events.
 
Arm/Group Title Male Female
Hide Arm/Group Description Male Participants Female Participants
All-Cause Mortality
Male Female
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Male Female
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Male Female
Affected / at Risk (%) Affected / at Risk (%)
Total   2/35 (5.71%)   2/35 (5.71%) 
General disorders     
Application Site Pain (burning, stinging)  1  1/35 (2.86%)  2/35 (5.71%) 
Application Site Erythema (redness)  1  1/35 (2.86%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Study is considered a work made for hire and the Sponsor retains all rights to publish results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joyce Hauze, Sr. Specialist
Organization: Johnson & Johsnon Consumer and Personal Products Worldwide
Phone: 9285-277-0715
EMail: jhauze@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01189617    
Other Study ID Numbers: KOYNAP0011
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: April 26, 2013
Results First Posted: January 10, 2014
Last Update Posted: February 27, 2017