Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids
| Authors | |
|---|---|
| Year of publication | 2015 |
| Type | Article in Periodical |
| Magazine / Source | Fertility and Sterility |
| MU Faculty or unit | |
| Citation | |
| Doi | http://dx.doi.org/10.1016/j.fertnstert.2014.10.038 |
| Field | Gynaecology and obstetrics |
| Keywords | Repeated intermittent use; ulipristal acetate; uterine fibroid; quality of life; long-term treatment |
| Description | 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. |