Long-term treatment of uterine fibroids with ulipristal acetate

Donnez, J. et al. (2014) Long-term treatment of uterine fibroids with ulipristal acetate. Fertility and Sterility, 101(6), 1565-1573.e18. (doi: 10.1016/j.fertnstert.2014.02.008)

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Abstract

Objective: To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids.<p></p> Design: Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo.<p></p> Setting: European clinical gynecology centers.<p></p> Patient(s): Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding.<p></p> Intervention(s): Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo.<p></p> Main Outcome Measure(s): Amenorrhea, fibroid volume, endometrial histology.<p></p> Result(s): After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2–6 days). Median fibroid volume change was −45% (interquartile range, −66%; −25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were −63%, −67%, and −72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology.<p></p> Conclusion(s): Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Barlow, Professor David
Authors: Donnez, J., Vázquez, F., Tomaszewski, J., Nouri, K., Bouchard, P., Fauser, B. C.J.M., Barlow, D. H., Palacios, S., Donnez, O., Bestel, E., Osterloh, I., and Loumaye, E.
College/School:College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Fertility and Sterility
Publisher:Elsevier Inc.
ISSN:0015-0282
ISSN (Online):1556-5653
Copyright Holders:Copyright © 2014 The Authors
First Published:First published in Fertility and Sterility 101(6):1565-1573.e18
Publisher Policy:Reproduced under a Creative Commons License

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