title: Ulipristal acetate versus leuprolide acetate for uterine fibroids.
abstract: BACKGROUND
  The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear.
  
  
  METHODS
  In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%.
  
  
  RESULTS
  Uterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 percentage points (95% confidence interval [CI], -9.3 to 11.8) for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate).
  
  
  CONCLUSIONS
  Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes. (Funded by PregLem; ClinicalTrials.gov number, NCT00740831.).
authors.affiliation: Cliniques Universitaires Saint-Luc Catholic University of Louvain, Brussels, Belgium. jacques.donnez@uclouvain.be
authors.forename: Jacques
authors.initials: J
authors.lastname: Donnez
authors.forename: Janusz
authors.initials: J
authors.lastname: Tomaszewski
authors.forename: Francisco
authors.initials: F
authors.lastname: Vázquez
authors.forename: Philippe
authors.initials: P
authors.lastname: Bouchard
authors.forename: Boguslav
authors.initials: B
authors.lastname: Lemieszczuk
authors.forename: Francesco
authors.initials: F
authors.lastname: Baró
authors.forename: Kazem
authors.initials: K
authors.lastname: Nouri
authors.forename: Luigi
authors.initials: L
authors.lastname: Selvaggi
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Sodowski
authors.forename: Elke
authors.initials: E
authors.lastname: Bestel
authors.forename: Paul
authors.initials: P
authors.lastname: Terrill
authors.forename: Ian
authors.initials: I
authors.lastname: Osterloh
authors.forename: Ernest
authors.initials: E
authors.lastname: Loumaye
mesh_terms: D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D057194:Intention to Treat Analysis; D007889:Leiomyoma / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D016729:Leuprolide / Q000009:adverse effects / Q000627:therapeutic use*; D008595:Menorrhagia / Q000188:drug therapy* / Q000209:etiology; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014594:Uterine Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D055815:Young Adult
chemical_list: D009649:Norpregnadienes; D016729:Leuprolide; C555622:ulipristal acetate