Trial Outcomes & Findings for A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions (NCT NCT00779025)

NCT ID: NCT00779025

Last Updated: 2011-10-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2011-10-07

Participant Flow

Participant milestones

Measure	Overall Study (ITT) The group evaluated was based on intention to treat (ITT).
Overall Study STARTED	82
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Overall Study (ITT) The group evaluated was based on intention to treat (ITT).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall Study (ITT) n=82 Participants The group evaluated was based on intention to treat (ITT).
Age, Customized Male	42.3 Years STANDARD_DEVIATION 14.5 • n=5 Participants
Age, Customized Female	40.0 Years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Analysis was per Intention to Treat (ITT)

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

Outcome measures

Measure	MINE Alone n=42 Participants Female Personal Lubricant (PD-F-5254)	YOURS and MINE n=40 Participants Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Number of Participants Showing Change From Baseline in Irritation Scores	0 Participants 0	0 Participants 0

SECONDARY outcome

Timeframe: 1 Week

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

Outcome measures

Measure	MINE Alone n=42 Applications Female Personal Lubricant (PD-F-5254)	YOURS and MINE n=40 Applications Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Number of Sensations Experienced by Male Subjects - Overall Itching	0 Sensations	0 Sensations
Number of Sensations Experienced by Male Subjects - Overall Burning	2 Sensations	0 Sensations
Number of Sensations Experienced by Male Subjects - Overall Stinging	2 Sensations	3 Sensations
Number of Sensations Experienced by Male Subjects - Overall Tingling	16 Sensations	15 Sensations
Number of Sensations Experienced by Male Subjects - Overall Warming	22 Sensations	24 Sensations

SECONDARY outcome

Timeframe: 1 Week

Population: Intention to Treat

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

Outcome measures

Measure	MINE Alone n=42 Applications Female Personal Lubricant (PD-F-5254)	YOURS and MINE n=40 Applications Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
Number of Sensations Experienced by Female Subjects - Overall Itching	1 Sensations	0 Sensations
Number of Sensations Experienced by Female Subjects - Overall Burning	4 Sensations	6 Sensations
Number of Sensations Experienced by Female Subjects - Overall Stinging	4 Sensations	0 Sensations
Number of Sensations Experienced by Female Subjects - Overall Tingling	25 Sensations	22 Sensations
Number of Sensations Experienced by Female Subjects - Overall Warming	31 Sensations	22 Sensations

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations

Johnson & Johnson Consumer and Personal Products Worldwide

Phone: 928-277-0715

Email: jhauze@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place