Clinical trial: In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products (NCT01813162)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-50 years, inclusive

          -  General good health (by volunteer history and per investigator discretion)

          -  History of and currently regular menstrual cycles

          -  Willing to abstain from the use of vaginal products, other than the TFV gel and her
             assigned study vaginal product for the duration of the study.

          -  Willing to abstain from sex and other vaginal activity during each crossover period
             starting 72 hours prior to initiating product use, for the duration of use, and until
             the sixth day following sample collection

          -  At low risk for pregnancy due to surgical sterilization of participant and/or her
             sexual partner, use of copper IUD or male condom, abstinence, or same sex relationship

          -  Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
             easy genital tract sample collection

          -  History of Pap smears and follow-up consistent with ACOG practice guidelines

          -  Negative urine pregnancy test

          -  Willing to give voluntary consent, sign an informed consent form and comply with study
             procedures as required by the protocol

        Exclusion Criteria:

          -  History of hysterectomy

          -  Currently pregnant/within 2 calendar months from the last pregnancy outcome.

          -  Use of Depo-Provera in the last 120 days or any hormonal contraceptives in the last
             month

          -  Currently breastfeeding or having breastfed an infant in the last 2 months, or
             planning to breastfeed during the course of the study

          -  History of sensitivity/allergy to any component of:

               -  TFV 1% gel; or

               -  topical anesthetic, or allergy to both silver nitrate and Monsel's solution.

          -  Contraindication to any of 3 vaginal products (antifungal cream, antimicrobial gel, or
             the combination contraceptive vaginal ring) to which participants may be randomized

          -  In the last 6 months, diagnosed with or treated for any STI or pelvic inflammatory
             disease, by self report.

          -  Symptomatic BV

          -  Positive test for Trichomonas vaginalis at Visit 1

          -  Positive test for Neisseria gonorrhea or Chlamydia trachomatis

          -  Positive test for HIV

          -  Positive test for Hepatitis B surface antigen (HBsAg)

          -  Known bleeding disorder that could lead to prolonged or continuous bleeding with
             biopsy

          -  Chronic or acute vulvar or vaginal symptoms

          -  Known current drug or alcohol abuse which could impact study compliance

          -  Grade 2 or higher laboratory abnormality, per the August 2009 update of the DAIDS
             Table for Grading the Severity of Adverse Events

          -  Systemic use in the last 2 weeks or anticipated use during the study of any of the
             following: corticosteroids, antibiotics, anticoagulants or other drugs known to
             prolong bleeding and or clotting, antifungals, antivirals (e.g., acyclovir or
             valacyclovir) or antiretrovirals (e.g., Viread®).

          -  Participation in any other drug or device interventional investigational trial
             (device, drug, or vaginal trial) within 30 days of this study or planned participation
             in any other investigational trial during the study

          -  History of gynecological procedures (including genital piercing) on the external
             genitalia, vagina or cervix within the last 14 days

          -  Abnormal finding on laboratory or physical examination or a social or medical
             condition which, in the opinion of the investigator, would make participation in the
             study unsafe or would complicate interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0