A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00779025
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 80.5

Study Details

Study Description

Brief Summary

The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Condition or Disease	Intervention/Treatment	Phase
Coitus	Device: PD-F-5254; Device: 10855-096	N/A

Detailed Description

Study to evaluate the safety of Class II personal lubricant devices.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MINE Alone Female Personal Lubricant (PD-F-5254)	Device: PD-F-5254; Female Personal Lubricant (MINE); Other Names: K-Y
Experimental: YOURS and MINE Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)	Device: PD-F-5254; Female Personal Lubricant (MINE); Other Names: K-Y ; Device: 10855-096; Male Personal Lubricant (YOURS); Other Names: K-Y

Outcome Measures

Primary Outcome Measures

1. Number of Participants Showing Change From Baseline in Irritation Scores [1 week]

   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

Secondary Outcome Measures

1. Number of Sensations Experienced by Male Subjects - Overall [1 Week]

   Number of sensations experienced by male subjects, based on two applications of the investigational product.

2. Number of Sensations Experienced by Female Subjects - Overall [1 Week]

   Number of sensations experienced by female subjects, based on two applications of the product for each subject.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Normal, healthy males and females >18 years of age

• In committed heterosexual relationship for >6months

• On acceptable method of birth control

Exclusion Criteria:

• Pregnant or breastfeeding

• Allergy to product ingredients

• Irritation or infection in genital area

• Unstable or uncontrolled medical condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Concentrics Center for Research	Indianapolis	Indiana	United States	46240

Sponsors and Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Study Director: Rita Wanser, J&J CPPW

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT00779025
• Other Study ID Numbers: CA-P-6020-1
• First Posted: Oct 24, 2008
• Last Update Posted: Oct 7, 2011
• Last Verified: Oct 1, 2011

Study Results

Participant Flow

Arm/Group Title	Overall Study (ITT)
Arm/Group Description	The group evaluated was based on intention to treat (ITT).
Period Title: Overall Study
STARTED	82
COMPLETED	81
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Overall Study (ITT)
Arm/Group Description	The group evaluated was based on intention to treat (ITT).
Overall Participants	82
Age, Customized (Years) [Mean (Standard Deviation) ]
Male	42.3 (14.5)
Female	40.0 (13.3)
Sex: Female, Male (Count of Participants)
Female	41 50%
Male	41 50%
Region of Enrollment (participants) [Number]
United States	82 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Showing Change From Baseline in Irritation Scores
Description	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
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Analysis was per Intention to Treat (ITT)

Arm/Group Title	MINE Alone	YOURS and MINE
Arm/Group Description	Female Personal Lubricant (PD-F-5254)	Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Measure Participants	42	40
Number [Participants]	0 (0) 0%	0 (0) NaN

2. Secondary Outcome

Title	Number of Sensations Experienced by Male Subjects - Overall
Description	Number of sensations experienced by male subjects, based on two applications of the investigational product.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MINE Alone	YOURS and MINE
Arm/Group Description	Female Personal Lubricant (PD-F-5254)	Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Measure Participants	21	20
Measure Applications	42	40
Itching	0	0
Burning	2	0
Stinging	2	3
Tingling	16	15
Warming	22	24

3. Secondary Outcome

Title	Number of Sensations Experienced by Female Subjects - Overall
Description	Number of sensations experienced by female subjects, based on two applications of the product for each subject.
Time Frame	1 Week

Outcome Measure Data

Analysis Population Description

Intention to Treat

Arm/Group Title	MINE Alone	YOURS and MINE
Arm/Group Description	Female Personal Lubricant (PD-F-5254)	Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Measure Participants	21	20
Measure Applications	42	40
Itching	1	0
Burning	4	6
Stinging	4	0
Tingling	25	22
Warming	31	22

Adverse Events

Arm/Group Title	Overall Study
Arm/Group Description
All Cause Mortality
	Overall Study
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	0/82 (0%)
Other (Not Including Serious) Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	0/82 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.