Trial Outcomes & Findings for A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects (NCT NCT02737592)

Results Overview

Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

2 weeks

Results posted on

2017-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Subject Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Subject Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Subject n=33 Participants Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate
Age, Customized Age 20 - 60	33 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema

Outcome measures

Outcome measures
Measure	Healthy Subject n=33 Participants Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate
Number of Subjects With Observed Local Erythema Based on 5 Point Scale	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema

Outcome measures

Outcome measures
Measure	Healthy Subject n=33 Participants Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks Trojan "Simply Pleasure" Personal Lubricant: silicone base without sensate
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale	0 Participants

Adverse Events

Healthy Subject

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

Annahita Ghassemi

Church & Dwight Co., Inc

Phone: 6098061200

Email: [email protected]

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