To evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
TRIPLE
Enrollment
34
silicone base without sensate
Clinical Research Laboratories, LLC
Piscataway, New Jersey, United States
Number of Subjects With Observed Local Erythema Based on 5 Point Scale
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
Time frame: 2 weeks
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale
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
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.