A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
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.