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