A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
NCT ID: NCT00219778
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2004-12-31
2010-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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mifepristone
Eligibility Criteria
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Inclusion Criteria
* 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
25 Years
49 Years
FEMALE
No
Sponsors
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Poitiers University Hospital
OTHER
Principal Investigators
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Guillaume Magnin, Professor
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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Poitiers University Hospital
Poitiers, , France
Countries
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Other Identifiers
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RUFIB
Identifier Type: -
Identifier Source: org_study_id
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