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


Phase 2
25 Years
49 Years
Not Enrolling
Female
Leiomyoma

Thank you

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

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