OBJECTIVE: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. DESIGN: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. SETTING: Gynecology centers. PATIENT(S): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. INTERVENTION(S): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. MAIN OUTCOME MEASURE(S): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. RESULT(S): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL 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. The percentage of subjects with endometrial thickness ≥ 16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. CONCLUSION(S): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate. CLINICAL TRIAL REGISTRATION NUMBER: NCT01629563.

Centrul Medical EUROMED SRL Obstetrica Ginecologie Bucuresti Romania

Department of Obstetrics and Gynaecology Masaryk University and University Hospital Brno Brno Czech Republic

Department of Reproductive Medicine and Gynecology University Medical Center Utrecht Utrecht the Netherlands

Hamad Medical Corporation Qatar and University of Glasgow Glasgow United Kingdom

Hôpital Bicêtre APHP Service de Gynécologie Obstétrique Le Kremlin Bicêtre France

Institut de Recherche Expérimentale et Clinique Université Catholique de Louvain Brussels Belgium

Medical Company ARS Gynaecology Department No 5 Riga Latvia

ObsEva S A Plan Les Ouates Geneva Switzerland

Praxis für Frauenheilkunde Klinische Forschung und Weiterbildung Magdeburg Germany

PregLem S A Plan les Ouates Geneva Switzerland

Private Clinic Maxmeda Vilnius Lithuania

Service d'Endocrinologie Hôpital Saint Antoine Paris France

Société de Recherche pour l'Infertilité Brussels Belgium

Szent Anna Szuleszeti Nogyogyaszati es Ultrahang Maganrendelo Debrecen Hungary

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NCT01629563