title: Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids.
abstract: 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.
  
  
  METHODS
  Double-blind, randomized administration of two 12-week courses of ulipristal acetate.
  
  
  METHODS
  Gynecology centers.
  
  
  METHODS
  A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding.
  
  
  METHODS
  Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate.
  
  
  METHODS
  Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids.
  
  
  BACKGROUND
  NCT01629563 (PEARL IV).
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: 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: Institut de Recherche Expérimentale et Clinique (IREC), Université de Louvain, Centre Hospitalier Université (CHU) Université Catholique de Louvain (UCL) Mont-Godinne Dinant, Yvoir, 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: Arhendt
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-Assistance Publique-Hopitaux de Paris (APHP), Service de Gynécologie-Obstétrique, Le Kremlin, Bicêtre cedex, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: Hamad Medical Corporation, Women's Health Services, Qatar.
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: CROS NT Limited, Maidenhead.
authors.forename: Paul
authors.initials: P
authors.lastname: Terrill
authors.affiliation: OsterMed Ltd., Birmingham, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Osterloh
authors.affiliation: ObsEva SA, Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Ernest
authors.initials: E
authors.lastname: Loumaye
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000568:Amenorrhea / Q000175:diagnosis / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced / Q000175:diagnosis; D006801:Humans; D007889:Leiomyoma / Q000175:diagnosis* / Q000188:drug therapy*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000175:diagnosis; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects*; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy; D011788:Quality of Life; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D009649:Norpregnadienes; C555622:ulipristal acetate
keywords: Repeated intermittent use; long-term treatment; quality of life; ulipristal acetate; uterine fibroid