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Mifepristone for Treatment of Uterine Fibroids

NCT00712595 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-04-23

No results posted yet for this study

Summary

The objectives of this study are to estimate the efficacy and safety of the daily administration of mifepristone 5 mg versus 10 mg for three months for the treatment of uterine fibroids.

The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in about 40% after 3 months of treatment.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Mifepristone

Oral administration of Mifepristone 10 mg daily for three months

DRUG

Mifepristone

Oral administration of Mifepristone 5 mg, daily for three months

Sponsors & Collaborators

  • Mediterranea Medica S. L.

    lead OTHER

Principal Investigators

  • Josep LL. Carbonell, MD · Mediterranea Medica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-01-31
Completion
2009-03-31

Countries

  • Cuba

Study Locations

More Related Trials

Entities

Drugs

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 NCT00712595 on ClinicalTrials.gov