drugset / Trial / NCT03520439
Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis
Phase 2/3
Completed
134 enrolled
xinmei zhang
Anhui Province Cancer Hospital · collabFirst Affiliated Hospital of Wenzhou Medical University · collabHuzhou Maternity and Child Care Hospital · collabJiaxing Maternity and Child Health Care Hospital · collabJinhua Municipal Central Hospital · collabNingbo Maternity and Child Care Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabShaoxing People's Hospital · collabShaoxing Women and Children's Hospital · collabSir Run Run Shaw Hospital · collabTaizhou First People's Hospital · collabThe Affiliated Hospital of Medical School of Ningbo University · collabThe Central Hospital of Lishui City · collabThe People's Hospital of Quzhou · collabZhoushan Maternity and Infant Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2018-05-19
- Primary completion
- 2019-07-31
- Completion
- 2019-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 10 mg | Oral |