Clinical trial: Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use (NCT01421368)

Eligibility criteria:
Inclusion Criteria:

          -  Willing and able to use OCs or DMPA

          -  General good health (by volunteer history and investigator assessment) without any
             clinically significant systemic disease

          -  Currently having regular menstrual cycles of 25 to 35 days by volunteer report

          -  History of Pap smears and follow-up consistent with American Congress of Obstetricians
             and Gynecologists (ACOG) practice bulletin #99 or #109 or willing to undergo a Pap
             smear at Visit 1

          -  Willing to follow protocol requirements including abstinence, use of study condoms,
             and prohibited use of intravaginal products

          -  Willing to follow post-biopsy restrictions for at least 5 days following genital
             biopsies

          -  Meets one of the following criteria:

               1. Sexually abstinent and planning to remain abstinent for the duration of the
                  study.

               2. In a mutually monogamous relationship for at least the last 4 months with a male
                  partner who is at least 18 years of age, willing to use condoms, and has no known
                  HIV infection or risks for sexually transmitted infections (STIs)

               3. In a mutually monogamous same-sex relationship for at least the last 4 months
                  with a partner who is at least 18 years of age and has no known HIV infection or
                  risks for STIs

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

          -  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 or within 2 calendar months from the last pregnancy outcome. (Note:
             If recently pregnant must have had at least 2 spontaneous menses since pregnancy
             outcome.)

          -  Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
             transvaginal, implant, or hormonal intrauterine contraceptive device)

          -  Injection of DMPA in the last 6 months

          -  Protection from pregnancy by presence of a copper IUD

          -  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 the study product, or topical
             anesthetic, or allergy to both silver nitrate and Monsel's solution

          -  Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 6
             months. (Note: Women with a history of genital herpes or condylomata who have been
             asymptomatic for at least 6 months may be considered for eligibility.)

          -  Positive test for Trichomonas vaginalis, Neisseria gonorrhoeae or Chlamydia
             trachomatis

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

          -  Deep epithelial genital findings such as abrasions, ulcerations, or lacerations, or
             vesicles suspicious for STIs

          -  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 (e.g., pain, irritation, or spotting)

          -  Contraindications to the chosen contraceptive method

          -  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

          -  Participation in any other investigational trial (device, drug, or vaginal trial) in
             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 in 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

          -  Systemic use in the last two weeks or anticipated use during the study of any of the
             following: corticosteroids, antibiotics, antifungals, antivirals or antiretrovirals
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