Clinical trial: Exploratory Pharmacodynamic Study of Tenofovir-Based Products (NCT02722343)

Eligibility criteria:
Inclusion Criteria:

          -  General good health (by volunteer history and per investigator judgment) without any
             clinically significant systemic disease (including, but not limited to significant
             liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
             osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract,
             uterus and cervix

          -  Currently have regular menstrual cycles of 21-35 days by participant record

          -  Willing to abstain from vaginal intercourse and any other vaginal activity including
             use of vaginal products (tampons, spermicides, lubricants, and douches) other than
             study products:

               -  48 hours before Visit 2 until six days after Visit 2

               -  48 hours before Visit 3 until six days after Visit 4

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

          -  Estimated calculated creatinine clearance (eCcr) of at least 60 mL/min

          -  History of Pap smears and follow-up consistent with standard clinical practice as
             outlined in the study manual or willing to undergo a Pap smear at Visit 1

          -  Protected from pregnancy by one of the following:

               -  sterilization of either partner

               -  abstinence

               -  same sex relationship

               -  condoms

               -  combined contraceptives (including oral, patch)

               -  copper IUD

          -  Willing and able to comply with protocol requirements including swallowing tablets

          -  Willing to give voluntary consent and sign an informed consent form

        Exclusion Criteria:

          -  History of hysterectomy

          -  Currently pregnant or within two calendar months from the last pregnancy outcome.
             Note: if recently pregnant must have had at least two spontaneous menses since
             pregnancy outcome

          -  Injection of Depo-Provera in the last 10 months or use of other progestin-only based
             contraceptive (including hormonal IUD)

          -  Currently breastfeeding or planning to breastfeed during the course of the study

          -  History of sensitivity/allergy to any component of the study products, topical
             anesthetic, or to both silver nitrate and Monsel's solution

          -  In the last three months, diagnosed with or treated for any STI, by self report

          -  Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
             HIV, or Hepatitis B surface antigen (HBsAg) Note: Women with a history of genital
             herpes who have been asymptomatic for at least three months may be considered for
             eligibility

          -  Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding,
             discharge, etc.)

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

          -  Systemic use in the last two 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, or antivirals (e.g., acyclovir,
             valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®)

          -  Current or anticipated chronic use of NSAIDS, or Tylenol for the duration of the study

          -  Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS,
             National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the
             Severity of Adverse Events, or clinically significant laboratory abnormality as
             determined by the clinician

          -  Abnormal finding on laboratory or physical examination or a social or medical
             condition in either the volunteer or which, in the opinion of the investigator, would
             make participation in the study unsafe or would complicate interpretation of data

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

          -  Participation in any other investigational trial within the last 30 days 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
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment