Clinical trial: A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects (NCT02737852)

Eligibility criteria:
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 using adequate
             non-barrier method of birth control

          -  free from any vaginal disorders

          -  sexually active and 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 times 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
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 1