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

This study has been terminated.
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
First received: September 16, 2005
Last updated: April 4, 2016
Last verified: March 2010

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.

Condition Intervention Phase
Drug: mifepristone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

Resource links provided by NLM:

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas

Secondary Outcome Measures:
  • -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

Estimated Enrollment: 20
Study Start Date: December 2004
Study Completion Date: February 2010

Ages Eligible for Study:   25 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219778

Poitiers University Hospital
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
Principal Investigator: Guillaume Magnin, Professor Poitiers University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00219778     History of Changes
Other Study ID Numbers: RUFIB 
Study First Received: September 16, 2005
Last Updated: April 4, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Connective Tissue Diseases
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016