Trial Outcomes & Findings for A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects (NCT NCT02320227)
NCT ID: NCT02320227
Last Updated: 2017-03-10
Results Overview
Number of participants with observed local erythema by OB/GYN examination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
14 Days
Results posted on
2017-03-10
Participant Flow
Participant milestones
| Measure |
Experimental: Healthy Subjects
Novel Personal Lubricant Miami w/o Fragrance
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects
Baseline characteristics by cohort
| Measure |
Experimental: Healthy Subjects
n=30 Participants
Novel Personal Lubricant Miami w/o Fragrance
|
|---|---|
|
Age, Customized
Age 22-59
|
30 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 DaysNumber of participants with observed local erythema by OB/GYN examination.
Outcome measures
| Measure |
Miami w/o Frag Personal Lubricant
n=30 Participants
Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
|
|---|---|
|
Number of Participants With Observed Local Erythema
|
0 participants
|
PRIMARY outcome
Timeframe: 14 daysNumber of participants with observed edema by OB/GYN examination.
Outcome measures
| Measure |
Miami w/o Frag Personal Lubricant
n=30 Participants
Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
|
|---|---|
|
Number of Participants With Observed Local Edema
|
0 participants
|
Adverse Events
Experimental: Healthy Subjects
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
Results disclosure agreements
- Principal investigator is a sponsor employee Master service agreement and confidentiality agreement in place
- Publication restrictions are in place
Restriction type: OTHER