A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
NCT03210324 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 434
Last updated 2019-08-07
Summary
To investigate the efficacy and adverse effects of mifepristone tablets in widely used conditions, to evaluate the relationship between interests and risks used in general or special populations, to further observe the safety and efficacy of drugs.
Conditions
- Uterine Fibroid
Interventions
- DRUG
-
Mifepristone tablets
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Sponsors & Collaborators
-
China Resources Zizhu Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yingfang Zhou, M.D. · Beijing Univesitay First Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-01
- Primary Completion
- 2019-01-04
- Completion
- 2019-07-12
Countries
- China
Study Locations
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