Clinical trial: Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs) (NCT00829114)

Eligibility criteria:
Inclusion Criteria:

          -  Willing to provide informed consent

          -  Willing to take COCs and follow all study requirements

          -  Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)

          -  Last menstrual period (LMP) <35 days before study entry

          -  Has body mass index of 18-30

          -  Negative urine pregnancy test as enrollment

          -  Documented HIV-1 infection

          -  On nevirapine-containing ART for at least three months (ART group only)

          -  CD4 cell count of greater than or equal to 350 (for non-ARV group only)

          -  Currently sexually active and plans to stay sexually active for the next 6 months

        Exclusion Criteria:

          -  Medical contraindications to COC use

          -  Recent pregnancy (within 3 months)

          -  Has breastfed in last 3 months

          -  Last pregnancy was ectpoic

          -  Has been sterilized

          -  Has had any of the following conditions since last pregnancy, or since menarche if
             never pregnant:

        Pelvic Inflammatory disease Diagnosis of infertility

          -  Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has
             had no menses since last injection regardless of its timing)

          -  has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin
             implants or intrauterine systems, progestin-only contraceptive pills,
             medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study
             entry

          -  Has an acute infection or other opportunistic diseases requiring therapy within 14
             days before enrollment

          -  Has active drug or alcohol use that, in the opinion of the investigator, would
             interfere with adherence to study requirements

          -  Has taken any prohibited medication within 30 days before study entry

          -  Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake

          -  Has any condition (social or medical) which in the opinion of the investigator would
             make study participation unsafe or complicate data interpretation
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 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? Contradiction