title: Ulipristal acetate versus placebo for fibroid treatment before surgery.
abstract: BACKGROUND
  The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain.
  
  
  METHODS
  We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery.
  
  
  RESULTS
  At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P=0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P=0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo.
  
  
  CONCLUSIONS
  Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids. (Funded by PregLem; ClinicalTrials.gov number, NCT00755755.).
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: Tetyana F
authors.initials: TF
authors.lastname: Tatarchuk
authors.forename: Philippe
authors.initials: P
authors.lastname: Bouchard
authors.forename: Lucian
authors.initials: L
authors.lastname: Puscasiu
authors.forename: Nataliya F
authors.initials: NF
authors.lastname: Zakharenko
authors.forename: Tatiana
authors.initials: T
authors.lastname: Ivanova
authors.forename: Gyula
authors.initials: G
authors.lastname: Ugocsai
authors.forename: Michal
authors.initials: M
authors.lastname: Mara
authors.forename: Manju P
authors.initials: MP
authors.lastname: Jilla
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; D000740:Anemia / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D007889:Leiomyoma / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D008595:Menorrhagia / Q000188:drug therapy* / Q000209:etiology; D008875:Middle Aged; D009649:Norpregnadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011980:Receptors, Progesterone / Q000037:antagonists & inhibitors*; D014594:Uterine Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D014599:Uterus / Q000473:pathology; D055815:Young Adult
chemical_list: D009649:Norpregnadienes; D011980:Receptors, Progesterone; C555622:ulipristal acetate