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

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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

Interventional


Primary Outcome

changes in chronic pelvic pain associated with adenomyosis

Secondary Outcome

 changes in uterine bleeding

Condition

Adenomyosis

Intervention

Mifepristone

Study Arms / Comparison Groups

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

Publications

* 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

Drug

Estimated Enrollment

134

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
             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.
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03520439

Organization ID

MF2018


Responsible Party

Sponsor-Investigator

Study Sponsor

xinmei zhang

Collaborators

 Anhui Province Cancer Hospital

Study Sponsor

, , 


Verification Date

October 2019