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

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... 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.