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Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

NCT00886873 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-10-17

No results posted yet for this study

Summary

The objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time.

The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Mifepristone

Sponsors & Collaborators

  • Mediterranea Medica S. L.

    lead OTHER

Principal Investigators

  • Carbonell Josep Ll., MD · Mediterranea Medica S. L.

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
2008-05-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • Cuba

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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 NCT00886873 on ClinicalTrials.gov