Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Mifepristone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating; Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
Other intervention name(s): RU486
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adenomyosis; mifepristone; the selective progesterone receptor modulators; treatment