Back to resultsA Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Primary Purpose
Leiomyoma
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
mifepristone
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma
Eligibility Criteria
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
Sites / Locations
- Poitiers University Hospital
Outcomes
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
Full Information
NCT ID
NCT00219778
First Posted
September 16, 2005
Last Updated
April 4, 2016
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00219778
Brief Title
A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Official Title
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mifepristone
Primary Outcome Measure Information:
Title
To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Secondary Outcome Measure Information:
Title
-To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
Title
-To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Magnin, Professor
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
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