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

Church & Dwight

Status

Completed

Conditions

Edema

Erythema

Treatments

Device: Trojan "Simply Pleasure" Personal Lubricant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02737592

ST-7610

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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