MedTrace Logo

Mifepristone to Treat Uterine Fibroids

NCT01786226 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-09-05

No results posted yet for this study

Summary

Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.

The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Oral administration of mifepristone 2.5 mg daily for three months

Experimental: 1

DRUG

Oral administration of mifepristone 5 mg daily for three months

Experimental: 2

Sponsors & Collaborators

  • Mediterranea Medica S. L.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Cuba

More Related Trials

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 NCT01786226 on ClinicalTrials.gov