Trial Information
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Principal Investigator
Guillaume Magnin, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Poitiers University Hospital
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
RUFIB
NCT ID:
NCT00219778
Start Date:
December 2004
Completion Date:
February 2009
Related Keywords:
- Leiomyoma
- Leiomyoma
- Myofibroma