Long-term treatment of uterine fibroids with ulipristal acetate ☆
Jacques Donnez, Francisco Vázquez, Janusz Tomaszewski, Kazem Nouri, Philippe Bouchard, Bart C J M Fauser, David H Barlow, Santiago Palacios, Olivier Donnez, Elke Bestel, Ian Osterloh, Ernest Loumaye, PEARL III and PEARL III Extension Study Group, Wlodzimierz Baranowski, David H Barlow, Francesco Baró, Pedro N Barri, Christine Bergeron, Elke Bestel, Philippe Bouchard, Sarah Brittain, Maria Jésus Cancelo Hidalgo, Francisco Carmona, Annie Dacquin, Jacques Donnez, Olivier Donnez, Bart C J M Fauser, Alex Ferenczy, Albrecht Giuliani, Javier Haya, Johannes Huber, Artur Jakimiuk, Florence S Jean, Jesus S Jimenez, Jan Kotarski, Boguslaw Lemieszczuk, Ernest Loumaye, Michelle Nisolle, Kazem Nouri, Ian Osterloh, Santiago Palacios, Anna Pawlaczyk, Krzysztof Sodowski, Rafal Sozanski, Jacek Suzin, Paul Terrill, Janusz Tomaszewski, Francisco Vázquez, Emilia Villegas, Alistair R W Williams, Jacques Donnez, Francisco Vázquez, Janusz Tomaszewski, Kazem Nouri, Philippe Bouchard, Bart C J M Fauser, David H Barlow, Santiago Palacios, Olivier Donnez, Elke Bestel, Ian Osterloh, Ernest Loumaye, PEARL III and PEARL III Extension Study Group, Wlodzimierz Baranowski, David H Barlow, Francesco Baró, Pedro N Barri, Christine Bergeron, Elke Bestel, Philippe Bouchard, Sarah Brittain, Maria Jésus Cancelo Hidalgo, Francisco Carmona, Annie Dacquin, Jacques Donnez, Olivier Donnez, Bart C J M Fauser, Alex Ferenczy, Albrecht Giuliani, Javier Haya, Johannes Huber, Artur Jakimiuk, Florence S Jean, Jesus S Jimenez, Jan Kotarski, Boguslaw Lemieszczuk, Ernest Loumaye, Michelle Nisolle, Kazem Nouri, Ian Osterloh, Santiago Palacios, Anna Pawlaczyk, Krzysztof Sodowski, Rafal Sozanski, Jacek Suzin, Paul Terrill, Janusz Tomaszewski, Francisco Vázquez, Emilia Villegas, Alistair R W Williams
Abstract
Objective: To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids.
Design: Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo.
Setting: European clinical gynecology centers.
Patient(s): Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding.
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.
Main outcome measure(s): Amenorrhea, fibroid volume, endometrial histology.
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.
Conclusion(s): Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids.
Clinical trial registration: ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).
Keywords: Long-term treatment; ulipristal acetate; uterine fibroid.
Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed