Clinical trial: Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives (NCT00089414)

Eligibility criteria:
-  INCLUSION CRITERIA (are from protocol 81-M-0126 and are as follows):

          -  Subjects who meet criteria for MRMD are healthy (by physical exam, normal pelvic exam
             and pap smear, and normal lab values) and medication free will be included in this
             study.

          -  Oral contraceptives (and CDB-2914 in arm #3) will not be administered to any subject
             with significant clinical or laboratory abnormalities.

        EXCLUSION CRITERIA:

        Any patient with a current axis I psychiatric diagnosis will be excluded from participating
        in this protocol.

        Subjects taking psychotropic agents (e.g. antidepressants, anxiolytics or mood stabilizers)
        will likewise be excluded from the study.

        Women who have received glucocorticoid or megestrol therapy within the last year (and thus
        may experience residual suppression of the compensatory HPA axis response to
        CDB-2914-induced glucocorticoid receptor antagonism) will be also excluded, albeit almost
        entirely on theoretical grounds.

        Women who have any chronic medical conditions or are taking medications will be excluded.

        Women who have a medical condition or are taking any chronic medications that may increase
        serum potassium levels will also be excluded.

        Those patients who would be uncomfortable with extending the length of their menstrual
        cycles will not be enrolled in this study and will either be offered participation in
        another study or an outside referral for treatment in the community.

        The following conditions will constitute contraindications to treatment with continuous
        oral contraception or the use of the progesterone antagonist, CDB-2914, and will preclude a
        patient's participating in this protocol:

          -  history of endometriosis, or recent, rapid growth of uterine fibroid tumors (defined
             as doubling in size in six month period);

          -  diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian
             enlargement;

          -  hepatic disease as manifested by abnormal liver function tests;

          -  history of breast carcinoma;

          -  history of pulmonary embolism or phlebothrombosis;

          -  undiagnosed vaginal bleeding;

          -  porphyria;

          -  history of malignant melanoma;

          -  history of cholecystitis or pancreatitis;

          -  history of hypercholesterolemia, hypertension, diabetes, or renal disease;

          -  recurrent migraine headaches (greater than or equal to 3 per year) in women 35 or
             older;

          -  pregnancy or lactation;

          -  cigarette smoking in women 35 or older, or more than 10 cigarettes per day in women
             under 35; or

          -  use of oral, injectable, or inhaled glucocorticoids or megestrol within the last year.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 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