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 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