Trial Outcomes & Findings for Safety Study for an All-in-One Body and Personal Lubricant (NCT NCT01189617)
NCT ID: NCT01189617
Last Updated: 2017-02-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Baseline and One Week
Results posted on
2017-02-27
Participant Flow
Participant milestones
| Measure |
Male
Male Participants
|
Female
Female Participants
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study for an All-in-One Body and Personal Lubricant
Baseline characteristics by cohort
| Measure |
Male
n=35 Participants
Male Participants
|
Female
n=35 Participants
Female Participants
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Other [unknown]
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Female Sub-Typing - Menopausal State
Premenopausal
|
NA Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Female Sub-Typing - Menopausal State
Postmenopausal
|
NA Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
50.25 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Gender
Male
|
35 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and One WeekPopulation: Full Analysis Set
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.
Outcome measures
| Measure |
Male
n=35 Participants
Male Participants
|
Female
n=35 Participants
Female Participants
|
|---|---|---|
|
Number of Subjects With Irritation Score of "0" at Baseline and One Week
Visit 1 - Baseline
|
35 Participants
|
35 Participants
|
|
Number of Subjects With Irritation Score of "0" at Baseline and One Week
Visit 2 - One Week
|
35 Participants
|
35 Participants
|
Adverse Events
Male
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Female
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Male
n=35 participants at risk
Male Participants
|
Female
n=35 participants at risk
Female Participants
|
|---|---|---|
|
General disorders
Application Site Pain (burning, stinging)
|
2.9%
1/35 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
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.
|
5.7%
2/35 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
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.
|
|
General disorders
Application Site Erythema (redness)
|
2.9%
1/35 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
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.
|
0.00%
0/35 • 1 Week (+30 days for Serious Adverse Events, and beyond if assessed as possibly treatment related)
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.
|
Additional Information
Joyce Hauze, Sr. Specialist
Johnson & Johsnon Consumer and Personal Products Worldwide
Phone: 9285-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study is considered a work made for hire and the Sponsor retains all rights to publish results.
- Publication restrictions are in place
Restriction type: OTHER