Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03520439
Study type Interventional
Source Women's Hospital School Of Medicine Zhejiang University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 19, 2018
Completion date October 1, 2019

See also
  Status Clinical Trial Phase
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Recruiting NCT04209127 - Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis N/A
Completed NCT05751876 - Dienogest in Perimenopausal Women With Adenomyosis
Recruiting NCT01048931 - Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Phase 3
Active, not recruiting NCT06223464 - Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
Completed NCT05419414 - The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis N/A
Recruiting NCT05152667 - Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
Not yet recruiting NCT03654144 - Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Phase 4
Completed NCT01992718 - What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Early Phase 1
Completed NCT02192606 - Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? N/A
Recruiting NCT02495311 - The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
Recruiting NCT03742843 - A Multi-omics Study of Adenomyosis
Recruiting NCT04481321 - Clinical and Molecular Study of Endometriosis and Adenomyosis
Recruiting NCT04894292 - The Effect of Adenomoyosis on Pregnancy Outcomes
Recruiting NCT05937490 - Adenomyosis and ART Phase 4
Recruiting NCT06373822 - New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
Completed NCT01821001 - Vaginal Bromocriptine for Treatment of Adenomyosis Phase 1
Recruiting NCT04295109 - Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function N/A
Recruiting NCT04356664 - Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Phase 2/Phase 3
Active, not recruiting NCT04791033 - Quality of Life After Hysterectomy (AdenoQOL)