Clinical trial: Relationship Between the Menstrual Cycle and Heart Disease in Women (NCT01546454)

Eligibility criteria:
Inclusion Criteria:

          -  Normal menstrual cycles of 25-35 days in length for at least previous 3 cycles

          -  21-40 years of age

          -  BMI > 18, < 30

          -  Serum P4 > 9 ng/ml on single sample collected between days 18-25 of self-reported
             menstrual cycle

          -  Flexible schedule allowing morning blood draws on less than 48 hour notice

          -  In good general health

          -  Commit to remain on stable diet during study period (no changes to normal dietary
             habits)

          -  Commit to using non-hormonal contraceptive methods during study period except those
             prescribed in the experimental protocol

          -  No objections to taking study drugs

        Exclusion Criteria:

          -  Oral contraceptive use or other hormone supplement within the preceding 2 months

          -  Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera®)

          -  Contraindications to study drugs

          -  Current or past pregnancy within the previous 6 months or currently trying to conceive

          -  Desiring to conceive in the next 8 months

          -  Breastfeeding in the past 2 months

          -  Diagnosed Diabetes or Metabolic Syndrome

          -  Current or previous use of cholesterol lowering drugs within the preceding 12 months

          -  Diagnosed Polycystic Ovary Syndrome

          -  History of, or self-reported, substance abuse

          -  Smoker

          -  Previous infertility treatment excluding male factor issues

          -  Use of an investigational drug within the past 2 months
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 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