Publication details

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

Authors

DONNEZ Jacques HUDEČEK Robert DONNEZ Olivier MATULE Dace ARHENDT Hans-Joachim ZATIK Janos KASILOVSKIENE Zaneta DUMITRASCU Mihai Cristian FERNANDEZ Hervé BARLOW David H. BOUCHARD Philippe FAUSER Bart C.J.M. BESTEL Elke TERRILL Paul OSTERLOH Ian LOUMAYE Ernest

Year of publication 2015
Type Article in Periodical
Magazine / Source Fertility and Sterility
MU Faculty or unit

Faculty of Medicine

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.

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