Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids

Jacques Donnez, Robert Hudecek, Olivier Donnez, Dace Matule, Hans-Joachim Arhendt, Janos Zatik, Zaneta Kasilovskiene, Mihai Cristian Dumitrascu, Hervé Fernandez, David H. Barlow, Philippe Bouchard, Bart C.J.M. Fauser (+4 others)
2015 Fertility and Sterility  
Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of two 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. Intervention(s): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. Main
more » ... utcome Measure(s): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. Result(s): In the 5-and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events.
doi:10.1016/j.fertnstert.2014.10.038 pmid:25542821 fatcat:umdudsasdzggpnnixjnwaptgi4