A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

April 4, 2016 updated by: Poitiers University Hospital

A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.

Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • Poitiers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients who are willing and able to participate in the study
  • patients from whom written informed consent has been obtained
  • patients who contribute to the National Insurance Scheme
  • patients with an age between 25 and 49 years old
  • non menopausal patients
  • patients who use a non hormonal contraception
  • patients with one or several , interstitial or subserous, uterine leiomyomas
  • echographic diameter of leiomyomas must be equal or higher than 30 mm
  • leiomyomas must be symptomatic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas

Secondary Outcome Measures

Outcome Measure
-To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
-To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Guillaume Magnin, Professor, Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUFIB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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