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

This study has been terminated.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00219778
First received: September 16, 2005
Last updated: March 2, 2010
Last verified: March 2010

September 16, 2005
March 2, 2010
December 2004
Not Provided
To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Same as current
Complete list of historical versions of study NCT00219778 on ClinicalTrials.gov Archive Site
  • -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
Same as current
Not Provided
Not Provided
 
A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Leiomyoma
Drug: mifepristone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
February 2009
Not Provided

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
Female
25 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00219778
RUFIB
Not Provided
Not Provided
Poitiers University Hospital
Not Provided
Principal Investigator: Guillaume Magnin, Professor Poitiers University Hospital
Poitiers University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP