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

Not Applicable

Completed

Conditions: Edema
Erythema

Interventions: Device: Trojan "Simply Pleasure" Personal Lubricant

Registration Number: NCT02737592

Lead Sponsor: Church & Dwight Company, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 34

Inclusion Criteria

no participation in a similar study 2-weeks prior
may be post-menopausal or have had a hysterectomy
if sexually active, and of child bearing potential, subjects is using adequate non-barrier method of birth control
free from any vaginal disorders
sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active
personal lubricant user and agrees to replace her usual personal lubricant with the investigational product
can start regardless of where they are in their cycles
agrees to use the provided investigational product at least four time weekly over the two week study period
exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam
willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study
agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area
willing to use a urine pregnancy test provided to them at baseline and on third visit
standard medical history form on file
signed informed consent
completed HIPAA
dependable and able to follow directions as outlined
receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.

Exclusion Criteria

pregnant, nursing or planning a pregnancy
currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines
known allergies to vaginal or any cosmetic products
reports history of recurrent bladder, vaginal infections or incontinence
exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation
uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception
participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation
receives a score higher than 0/5 for erythema, edema or >0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subject	Trojan "Simply Pleasure" Personal Lubricant	Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale	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
Number of Subjects With Observed Local Erythema Based on 5 Point Scale	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

Secondary Outcome Measures