Clinical trial: SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study (NCT00511797)

Eligibility criteria:
Inclusion Criteria:

          -  Patients aged 20 years or older at obtaining informed consent

          -  Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses
             before the final enrollment

          -  Patients having a total dysmenorrhea score of at least 3 points in two menstrual
             cycles before the final enrollment

        Exclusion Criteria:

          -  Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in
             greater detail in the study protocol)

          -  Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine
             body or breast fibrocystic, etc.), and patients with cervical cancer or suspected
             cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear
             examination.)

          -  Patients with undiagnosed abnormal vaginal bleeding

          -  Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including
             transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial
             infarction and angina pectoris, etc.), or a history of those diseases

          -  Patients aged 35 years or older who smoke at least 15 cigarettes per day

          -  Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or
             star-shaped scintillation)

          -  Patients with pulmonary hypertension or valvular heart disease complicated by atrial
             fibrillation, and patients with a history of subacute bacterial endocarditis

          -  Patients who are regularly taking nutritional products that contain St. John's Wort

          -  Patients who underwent surgical treatment for endometriosis by laparotomy, or
             laparoscopy within 2 months prior to screening

          -  Patients who need to use analgesics regularly for therapeutic objectives other than
             relief from the pain of dysmenorrhea during this study (occasional use permitted)
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? 1