Leiomyoma Clinical Trial
Official title:
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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