drugset / Trial / NCT05151016
Long-term Use of Mifepristone in the Treatment of Adenomyosis
Phase 0
Unknown
140 enrolled
Women's Hospital School Of Medicine Zhejiang University
Anhui Provincial Hospital · collabJiaxing Maternity and Child Health Care Hospital · collabNingbo Women & Children's Hospital · collabObstetrics & Gynecology Hospital of Fudan University · collabQilu Hospital of Shandong University · collabThe Affiliated Hospital of Medical School, Ningbo University · collabThe First Affiliated Hospital with Nanjing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 10 mg | Oral |
| Comparator | Triptorelin | Other / unclassified | 3.75 mg | Intramuscular |