drugset / Trial / NCT02357563

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

NCT02357563

Phase 4 Unknown 110 enrolled University Magna Graecia
RandomizedParallel-groupDouble-blindTreatment

Summary

Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

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