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 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction