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

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219778
• Other study ID #: RUFIB
• Status: Terminated
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: April 4, 2016
• Start date: December 2004
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• mifepristone

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Secondary	-To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
Secondary	-To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks