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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210324 on ClinicalTrials.gov