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Trial of Mifepristone for Fibroids

NCT00133705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-09-25

Study results available
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Summary

The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.

Conditions

  • Leiomyoma

Interventions

DRUG

Mifepristone

Mifepristone 5mg/day by mouth for 6 months

DRUG

Inert Capsule

sugar pill

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Kevin Fiscella, MD, MPH · University of Rochester School of Medicine & Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

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 NCT00133705 on ClinicalTrials.gov