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

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

Conditions

• Adenomyosis

Interventions

DRUG

Mifepristone

Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating

DRUG

Placebo

Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating

Sponsors & Collaborators

• Anhui Province Cancer Hospital

  collaborator UNKNOWN

• Huzhou Maternity and Child Care Hospital

  collaborator UNKNOWN

• Jiaxing Maternity and Child Health Care Hospital

  collaborator OTHER

• Jinhua Municipal Central Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• The Affiliated Hospital of Medical School of Ningbo University

  collaborator UNKNOWN

• Ningbo Maternity and Child Care Hospital

  collaborator UNKNOWN

• The People's Hospital of Quzhou

  collaborator OTHER

• Shaoxing Women and Children's Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Taizhou First People's Hospital

  collaborator OTHER

• Zhoushan Maternity and Infant Hospital

  collaborator UNKNOWN

• Shaoxing People's Hospital

  collaborator OTHER

• xinmei zhang

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-19

Primary Completion

2019-07-31

Completion

2019-10-01

Countries

• China

Study Locations