Overview

Long-term Use of Mifepristone in the Treatment of Adenomyosis

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The design was a prospective, randomized, positive-control, parallel-group, multicenter clinical trial. The study included a randomized, parallel-group treatment for 24 weeks in 140 subjects from eight hospitals in seven cities across the country who were diagnosed with Adenomyosis and associated symptoms (dysmenorrhea, with or without heavy menstrual flow) , the subjects were randomly assigned to the following two groups: 1. Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks; 2. Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Phase:
Early Phase 1
Details
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Collaborators:
Anhui Provincial Hospital
Jiaxing Maternity and Child Health Care Hospital
Ningbo Women & Children's Hospital
Obstetrics & Gynecology Hospital of Fudan University
Qilu Hospital of Shandong University
The Affiliated Hospital of Medical School, Ningbo University
The First Affiliated Hospital with Nanjing Medical University
Treatments:
Mifepristone
Triptorelin Pamoate