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

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