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

Learn more about:
Related Clinical Trial
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis Long-term Use of Mifepristone in the Treatment of Adenomyosis Radiofrequency Ablation of Adenomyosis Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis The Effect of Adenomoyosis on Pregnancy Outcomes Observational Study of Patients Suffering From Endometriosis and Adenomyosis Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Brief Title

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

Official Title

Mifepristone Versus Placebo to Treat Adenomyosis: a Double-blind, Multicentre,Randomized Clinical Trial

Brief 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

Detailed Description

      Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea
      and menorrhagia as the main clinical manifestations, which seriously harm the physical and
      mental health of the patients. Most patients have the desire to retain the uterus. Therefore,
      the treatment of drug conservative treatment is dominant in the treatment of adenomyosis.
      However, the current clinical treatment of adenomyosis still has some limitations and needs
      to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis.

      Mifepristone is defined as a selective progesterone receptor modulator. Under specific
      conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits
      ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in
      of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone
      related diseases, especially endometriosis. At present, the study of mifepristone in the
      treatment of adenomyosis is more extensive in China. A large number of domestic literature
      reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for
      the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had
      amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing
      the uterine and lesion volume of the patients with adenomyosis . However, most of the
      domestic literature is a small sample case control study or retrospective study. There is no
      randomized double blind control study. There is no clinical study on the application of
      mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is
      inadequate, and a high quality randomized controlled trial is still needed. The purpose of
      this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the
      treatment of symptomatic adenomyosis with multi center, random, double blind and controlled
      clinical trials. It is a new clinical study for the old medicine.

Study Phase

Phase 2/Phase 3

Study Type


Primary Outcome

changes in chronic pelvic pain associated with adenomyosis

Secondary Outcome

 changes in uterine bleeding





Study Arms / Comparison Groups

 study group
Description:  mifepristone tablets ,10mg,One tablet daily, oral treatment


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 19, 2018

Completion Date

October 1, 2019

Primary Completion Date

July 31, 2019

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

          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

          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




18 Years - 50 Years

Accepts Healthy Volunteers



, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

xinmei zhang


 Anhui Province Cancer Hospital

Study Sponsor

, , 

Verification Date

October 2019