Clinical trial: Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea (NCT01892904)

Eligibility criteria:
Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two
        sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of
        the last two menstruations before randomization (baseline observation phase)

          -  Patients with dysmenorrheic pain during the 2 baseline cycles before randomization.
             Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with
             possible radiation towards back or thighs recorded in the Patient Diary in
             correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start
             up to 2 days before the onset of the bleeding episode the bleeding and terminates on
             the last day of bleeding of before

          -  Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two
             menses before randomization (baseline observation phase)

          -  Willingness to use a barrier method (i.e., non-hormonal method) for contraception
             during the study. Acceptable methods of contraception include (i) condoms (male or
             female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with
             spermicide; (iii) intra-uterine device.

        Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is
        prioritized by the investigator

          -  Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in
             size of the longest diameters

          -  Patients with ovarian chocolate cysts having solid part in the cyst

          -  Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese
             Labeling)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.


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