Clinical trial: Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis (NCT03520439)

Eligibility criteria:
Inclusion Criteria:

          1. B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the
             subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy;

          2. Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without
             menorrhagia (PBAC≥100 points);

          3. Women between 18 and 50 years old who currently have no childbearing requirements;

          4. Normal or cervical cytology results without clinical significance (results within 6
             months before the screening period);

          5. Willing to choose a barrier method of contraception if contraception is needed;

          6. Be tested voluntarily and sign the informed consent.

          7. No menopause

        No menopause

        Exclusion Criteria:

          1. HB<90G/L

          2. Undiagnosed abnormal vaginal bleeding or endometrial lesions;

          3. Pregnancy and lactation women and those who are preparing to give birth when taking
             the medication or within 6 months of stopping the medication;

          4. Malignant tumors (including the reproductive system and other systems);

          5. The patients with severe heart, liver, kidney disease and adrenocortical
             insufficiency;

          6. The results of follow-up laboratory test indicate abnormal clinical significance;

          7. The allergic persons or those who have been allergic to multiple drugs, or are
             allergic to active ingredients or any excipients of the study drug;

          8. Suffering from any disease or condition that may cause the study drug to alter
             absorption, accumulate excessively, affect metabolism, or change the excretion
             pattern;

          9. Having clinically significant depression within the current or most recent year;

         10. People who regularly take analgesics due to other underlying diseases;

         11. Ketoconazole, itraconazole, erythromycin, rifampicin, corticosteroids (hydrocortisone,
             prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, phenobarbital,
             carbamazepine, etc.), griseofulvin, non-steroidal anti-inflammatory drugs (aspirin,
             acetaminophen, etc.) that are being used and cannot be stopped during the study;

         12. Previous use of hormone drugs, including: a. use of GnRH agonists within 6 months
             before the screening period; b. use of progestins or danazol and other long-acting
             hormones within 3 months before the screening period; c. use of oral
             contraceptive-like short-acting hormones within one month before the screening period;

         13. Patients who participated in other clinical trials within 3 months before the
             screening, or who are considered inappropriate to participate in the study by other
             investigators.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 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