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

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 Outcome 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. Conclusion(s) Repeated 12-week courses of daily oral ulipristal acetate (5-and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids. Clinical Trial Registration Number NCT01629563 (PEARL IV).