Trial Outcomes & Findings for A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects (NCT NCT02737852)

Results Overview

Number of subjects with observed local erythema by obstetrician/gynecologist 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

32 participants

Primary outcome timeframe

2 weeks

Results posted on

2017-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Subject Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Subject Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Subject n=30 Participants Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate
Age, Customized Age 19-59	30 Participants n=30 Participants
Sex: Female, Male Female	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of subjects with observed local erythema by obstetrician/gynecologist 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=30 Participants Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with sensate
Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of subjects with observed local edema by obstetrician/gynecologist 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=30 Participants Healthy subject exposed to Trojan "Chameleon" Personal Lubricant at least four times weekly for two weeks Trojan "Chameleon" Personal Lubricant: silicone base with 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