drugset / Trial / NCT02361905

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

NCT02361905

Phase 4 Unknown 42 enrolled University Magna Graecia
RandomizedParallel-groupDouble-blindTreatment

Summary

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.

Timeline

Start
2015-02
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leuprolide Other / unclassified 11.25 unknown Intramuscular
Subject Ulipristal Acetate Unknown 5 mg Oral

Indications