Clinical trial: Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel (NCT01369303)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-50 years, inclusive;

          -  General good health (by volunteer history and per investigator discretion) 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 type 2 diabetes);

          -  Currently having regular menstrual cycles, if not on hormonal (including continuous)
             contraception, by volunteer report and per investigator discretion;

          -  History of Pap smears and follow-up consistent with American Congress of Obstetricians
             and Gynecologist (ACOG) practice guideline #109 (see study manual) or willing to
             undergo a Pap smear at Visit 1. (Note: See study manual for clarification of
             eligibility criteria specific to Pap smear results.)

          -  Willing to abstain from the use of any vaginal product other than the study gel
             including spermicides, lubricants, vaginal hygiene products, contraceptive
             intravaginal ring, diaphragms, and cervical caps (non-hormonal IUC if used as her
             method of contraception, is allowed) for the duration of the study;

          -  In a monogamous relationship for at least the last four months with a male partner, at
             least 18 years old with no known risks for STIs, and not known to be HIV positive, who
             is willing and able to comply with the study requirements, and with whom condoms are
             not typically used;

          -  Protected from pregnancy by sterilization of either partner, use of combination oral
             contraceptives or patch for at least two cycles, or non-hormonal intrauterine
             contraception throughout the study. Continuous oral contraceptives are allowable if
             the patient is at low risk for breakthrough bleeding;

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

          -  Negative urine pregnancy test; and

          -  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 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;

          -  Use of Depo-Provera in the last 120 days;

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

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

          -  In the last six months, diagnosed with or treated for any STI or pelvic inflammatory
             disease. Note: Women with a history of genital herpes or condylomata who have been
             asymptomatic for at least six months may be considered for eligibility;

          -  Symptomatic vulvovaginal candidiasis, Nugent score greater than equal to 7 at
             screening or symptomatic bacterial vaginosis (BV) at Visit 2, or symptomatic urinary
             tract infection (UTI);

          -  Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis;

          -  Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
             vesicles suspicious for a sexually transmitted infection;

          -  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 (pain, irritation, spotting, etc.);

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

          -  Grade 1 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 two weeks or anticipated use during the study of drugs on a
             daily basis that may reduce renal function (e.g., ibuprofen) or liver function (e.g.,
             Tylenol®), or that may affect anti-HSV activity (e.g., acyclovir or valacyclovir) of
             any of the following: corticosteroids, antibiotics, antifungals, antivirals (e.g.
             acyclovir or valacylovir) or antiretrovirals (e.g. Viread®). Note: Participants should
             avoid nonsteroidal anti-inflammatory drugs (NSAIDs) except for treatment of
             dysmenorrhea during menses. Participants may use Tylenol® on an as-needed but not
             daily basis during the study

          -  Participation in any other investigational trial (device, drug, or vaginal
             trial)within the last 30 days for 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; and

          -  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? Contradiction