Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind, placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment groups and received one of the following treatments:

1. Mifepristone tablets of 10mg, 1 tablet daily, oral

2. Placebo, 1 tablet daily, oral

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: xinmei zhang
• Collaborators: Anhui Province Cancer Hospital; First Affiliated Hospital of Wenzhou Medical University; Huzhou Maternity and Child Care Hospital; Jiaxing Maternity and Child Health Care Hospital; Jinhua Municipal Central Hospital; Ningbo Maternity and Child Care Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shaoxing People's Hospital; Shaoxing Women and Children's Hospital; Sir Run Run Shaw Hospital; Taizhou First People's Hospital; The Affiliated Hospital of Medical School of Ningbo University; The Central Hospital of Lishui City; The People's Hospital of Quzhou; The People's Hospital of Quzhou City; Zhoushan Maternity and Infant Hospital
• Treatments: Mifepristone

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.