1569 The Efficacy and Safety of Long-Term Management of Uterine Fibroids with Ulipristal Acetate

Study Objective To investigate the efficacy and safety of four repeated 12-week courses of 5 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design A retrospective, single-center observational study. Setting A university tertiary referral center. Patients or Participants One hundred seventy-one premenopausal women with symptomatic uterine fibroids. Interventions Four repeated 12-week treatment courses of daily 5 mg ulipristal acetate. Measurements and Main Results After four repeated 12-week courses, uterine bleeding was controlled in 93% of the women receiving 5 mg of ulipristal acetate. The rates of amenorrhea were 83% occurring within 9 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were –17%. Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently. Pain 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. Conclusion The results of this study demonstrate the efficacy and further support the safety profile of four repeated 12-week courses of 5 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids.