title: Long-term treatment of uterine fibroids with ulipristal acetate ☆.
abstract: OBJECTIVE
  To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids.
  
  
  METHODS
  Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo.
  
  
  METHODS
  European clinical gynecology centers.
  
  
  METHODS
  Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding.
  
  
  METHODS
  Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo.
  
  
  METHODS
  Amenorrhea, fibroid volume, endometrial histology.
  
  
  RESULTS
  After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2-6 days). Median fibroid volume change was -45% (interquartile range, -66%; -25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were -63%, -67%, and -72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology.
  
  
  CONCLUSIONS
  Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids.
  
  
  BACKGROUND
  ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).
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: Centro de Estudios de Obstetricia y Ginecología Asociado, Lugo, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Vázquez
authors.affiliation: Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok, Poland.
authors.forename: Janusz
authors.initials: J
authors.lastname: Tomaszewski
authors.affiliation: Department of Gynecological Endocrinology and Reproductive Medicine, Medical School of Vienna, Vienna, Austria.
authors.forename: Kazem
authors.initials: K
authors.lastname: Nouri
authors.affiliation: Endocrinology Unit, AP-HP Hospital 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: College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, Scotland.
authors.forename: David H
authors.initials: DH
authors.lastname: Barlow
authors.affiliation: Palacios' Institute of Women's Health, Madrid, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Palacios
authors.affiliation: Centre Hospitalier Universitaire Université Catholique de Louvain Mont-Godinne Dinant, Yvoir, Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Donnez
authors.affiliation: PregLem S.A., Geneva, Switzerland.
authors.forename: Elke
authors.initials: E
authors.lastname: Bestel
authors.affiliation: OsterMed Ltd., Birmingham, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Osterloh
authors.affiliation: ObsEva S.A. Geneva, Switzerland.
authors.forename: Ernest
authors.initials: E
authors.lastname: Loumaye
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D005060:Europe; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D008595:Menorrhagia / Q000188:drug therapy / Q000209:etiology; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077563:Norethindrone Acetate; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D017699:Pelvic Pain / Q000188:drug therapy / Q000209:etiology; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden / Q000187:drug effects; D014594:Uterine Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009649:Norpregnadienes; D000077563:Norethindrone Acetate; D009640:Norethindrone; C555622:ulipristal acetate
keywords: Long-term treatment; ulipristal acetate; uterine fibroid