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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedApril 6, 2016
March 1, 2010
September 16, 2005
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Secondary Outcomes (2)
-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
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poitiers University Hospital
Poitiers, 86000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Magnin, Professor
Poitiers University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
December 1, 2004
Study Completion
February 1, 2010
Last Updated
April 6, 2016
Record last verified: 2010-03