title: Long-term medical management of uterine fibroids with ulipristal acetate.
abstract: 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.
  
  
  METHODS
  Double-blind, randomized administration of four 12-week courses of ulipristal acetate.
  
  
  METHODS
  Gynecology centers.
  
  
  METHODS
  Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding.
  
  
  METHODS
  Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate.
  
  
  METHODS
  Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate.
  
  
  BACKGROUND
  NCT01629563.
authors.affiliation: Société de Recherche pour l'Infertilité, Brussels, Belgium. Electronic address: jacques.donnez@gmail.com.
authors.forename: Jacques
authors.initials: J
authors.lastname: Donnez
authors.affiliation: Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Donnez
authors.affiliation: Medical Company ARS Gynaecology Department No. 5, Riga, Latvia.
authors.forename: Dace
authors.initials: D
authors.lastname: Matule
authors.affiliation: Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung, Magdeburg, Germany.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Ahrendt
authors.affiliation: Department of Obstetrics and Gynaecology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
authors.forename: Robert
authors.initials: R
authors.lastname: Hudecek
authors.affiliation: Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo, Debrecen, Hungary.
authors.forename: Janos
authors.initials: J
authors.lastname: Zatik
authors.affiliation: Private Clinic Maxmeda, Vilnius, Lithuania.
authors.forename: Zaneta
authors.initials: Z
authors.lastname: Kasilovskiene
authors.affiliation: Centrul Medical EUROMED SRL, Obstetrica-Ginecologie, Bucuresti, Romania.
authors.forename: Mihai Cristian
authors.initials: MC
authors.lastname: Dumitrascu
authors.affiliation: Hôpital Bicêtre-APHP, Service de Gynécologie-Obstétrique, Le Kremlin-Bicêtre, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: Hamad Medical Corporation, Qatar and University of Glasgow, Glasgow, United Kingdom.
authors.forename: David H
authors.initials: DH
authors.lastname: Barlow
authors.affiliation: Service d'Endocrinologie, Hôpital Saint-Antoine, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bouchard
authors.affiliation: Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: Bart C J M
authors.initials: BC
authors.lastname: Fauser
authors.affiliation: PregLem S.A., Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Elke
authors.initials: E
authors.lastname: Bestel
authors.affiliation: ObsEva S.A, Plan-Les-Ouates, Geneva, Switzerland.
authors.forename: Ernest
authors.initials: E
authors.lastname: Loumaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001706:Biopsy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D017699:Pelvic Pain / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D014594:Uterine Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D009649:Norpregnadienes; C555622:ulipristal acetate
keywords: Ulipristal acetate; bleeding; fibroid volume; long-term treatment; pain; uterine fibroid