Jacques Donnez, M.D., Olivier Donnez, M.D., Dace Matule, M.D., Hans-Joachim Ahrendt, M.D., Robert Hudecek, M.D., Janos Zatik, M.D., Zaneta Kasilovskiene, M.D., Mihai Cristian Dumitrascu, M.D., Hervé Fernandez, M.D., David H. Barlow, F.R.C.O.G., Philippe Bouchard, M.D., Bart C.J.M. Fauser, M.D., Elke Bestel, M.D., Ernest Loumaye, M.D.
Volume 105, Issue 1, Pages 165-173
To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids.
Double-blind, randomized administration of four 12-week courses of ulipristal acetate.
Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding.
Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate.
Main Outcome Measure(s):
Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain.
Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness ≥16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation.
The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate.
Clinical Trial Registration Number:
ClinicalTrials.gov (www.clinicaltrials.gov) registration number NCT01629563 (PEARL IV).
Read the full text at: http://www.fertstert.org/article/S0015-0282(15)01960-3/fulltext