title: Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids.
abstract: BACKGROUND
  Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). SPRMs are a new class of progesterone-receptor ligands that exert tissue selective agonist, antagonist or mixed agonist-antagonist activity in target cells. UPA inhibits the proliferation, induces apoptosis of leiomyoma cells in vitro and demonstrates potent progesterone antagonist activity in vitro and in vivo.
  
  
  METHODS
  This manuscript aims to review the available data on safety of UPA in the treatment of uterine fibroids. Data and articles included in this manuscript were obtained via PubMed, Medline and Embase up to November 2014.
  
  
  CONCLUSIONS
  UPA is efficacious in the treatment of uterine fibroids before surgery; it decreases leiomyoma volume and uterine bleeding; furthermore, it improves quality of life. Short-term administration of UPA has been shown to be safe at short follow-up (months) and it is associated with minimal adverse side effects; further studies with longer follow-up are required to define the safety profile of UPA on endometrial histology.
authors.affiliation: University of Genoa, IRCCS AOU San Martino - IST, Department of Obstetrics and Gynaecology , Largo Rosanna Benzi 1, 16132, Genova , Italy +00393477211682 ; +0039010511525 ; simone.ferrero@unige.it.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Tafi
authors.forename: Carolina
authors.initials: C
authors.lastname: Scala
authors.forename: Umberto
authors.initials: U
authors.lastname: Leone Roberti Maggiore
authors.forename: Nicolò
authors.initials: N
authors.lastname: Bizzarri
authors.forename: Massimo
authors.initials: M
authors.lastname: Candiani
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Venturini
authors.forename: Simone
authors.initials: S
authors.lastname: Ferrero
mesh_terms: D000818:Animals; D017209:Apoptosis / Q000187:drug effects; D049109:Cell Proliferation / Q000187:drug effects; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D009649:Norpregnadienes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011788:Quality of Life; D011980:Receptors, Progesterone / Q000187:drug effects; D013997:Time Factors; D014594:Uterine Neoplasms / Q000188:drug therapy*
chemical_list: D009649:Norpregnadienes; D011980:Receptors, Progesterone; C555622:ulipristal acetate
keywords: safety; selective progesterone-receptor modulators; tolerability; treatment; ulipristal acetate; uterine fibroids