Clinical trial: A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects (NCT02320227)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60
             years (no more than 9 subjects);

          -  Subject is using adequate non-barrier method of birth control [established us of
             hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine
             device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a
             monogamous relationship with male partner with vasectomy];

          -  Subject is free of any vaginal disorders;

          -  Subject is 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 (at least 50%
             and up to 100% of the study population) or is not sexually active (no more than 50% of
             the population);

          -  Subject is a personal lubricant user and agrees to replace her usual personal
             lubricant with the investigational product;

          -  Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before
             or after the examination days;

          -  Subject agrees to use the provided investigational product at least four times weekly
             (including at least twice weekly during sexual intercourse for subjects with
             monogamous, male partners) over the two-week study period;

          -  Subject 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
             examination;

          -  Subject is willing to refrain from introducing any new vaginal products, or using
             vaginal medication or local contraceptives (including condoms and hormonal rings),
             during the course of this study;

          -  Subject agrees to refrain from douching or using any medications, powder, lotions or
             personal care products in the vulvar or perianal area for the duration of the study
             (Note: subjects may continue to use their usual pantyliner, if any);

          -  Subject is willing to use a urine pregnancy test provided to them at baseline and on
             the third visit (Week 2, day 14);

          -  Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form
             on file at CRL and has completed study specific Medical History and Screener/Inclusion
             forms;

          -  Subject has signed and, if sexually active and in a monogamous relationship, whose
             partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50:
             "Protection of Human Subjects";

          -  Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in
             conformance with 45 CFR Parts 160 and 164;

          -  Subject is dependable and able to follow directions as outlined in the protocol;

          -  Subject 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:

          -  Subject is pregnant, nursing, or planning a pregnancy;

          -  Subject is post-menopausal or has had a hysterectomy;

          -  Subject is currently using, or has used within two weeks prior to study initiation,
             any systemic or topical corticosteroids, vasoconstrictors, antibiotics,
             anti-inflammatories, or antihistamines;

          -  Subject has known allergies to vaginal or any cosmetic products (including lotions,
             moisturizer, powder, sprays, etc.);

          -  Subject reports a history of recurrent bladder, vaginal infection, or incontinence;

          -  Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60
             days prior to study initiation.

          -  Subject is expected to menstruate 2-4 days before or after the time of the first,
             second, and third examination;

          -  Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms
             with spermicide as a means of contraception;

          -  Subject has participated in a study involving the vaginal area or in an
             investigational systemic drug study within two weeks of study initiation;

          -  Subject receives a score higher than 0.5 for erythema, edema, or >0 for burning,
             stinging, or itching, during the first examination or shows any other sign of mucosal
             irregularities (dryness, papules, vesticulation, fissure).
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? Entailment