title: Safety of treatment of uterine fibroids with the selective progesterone receptor modulator, ulipristal acetate.
abstract: During the last decade, there has been increased emphasis on the role of progesterone in the promotion of fibroid growth, as well as heightened interest in modulating progesterone pathways by use of selective progesterone receptor modulators (SPRMs). Among them, ulipristal acetate (UPA) has proved its efficacy in the management of symptomatic myomas by controlling bleeding and inducing amenorrhea, and reducing the size of myomas in the majority of cases. Areas covered: In this review, we summarize published scientific studies exploring evidence of the safety of SPRMs and particularly UPA, a drug approved for the management of symptomatic uterine fibroids. We focus essentially on endometrial changes induced by UPA, and also evaluate other safety outcomes. Expert opinion: Data from published reports of randomized controlled trials (RCTs) over 5 years have demonstrated that UPA does indeed induce endometrial changes (known as progesterone receptor modulator-associated endometrial changes), but they have been shown to be both benign and reversible.
authors.affiliation: a Society for Research in Infertility (SRI) , Brussels , Belgium.
authors.forename: Jacques
authors.initials: J
authors.lastname: Donnez
authors.affiliation: b Institut du Sein et de Chirurgie Gynécologique d'Avignon (ICA), Polyclinique Urbain V (Groupe Vedici-Vitalia), Chemin du Pont des Deux Eaux , Avignon , France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Donnez
authors.affiliation: c Pôle de Recherche en Gynécologie , Institut de Recherche Expérimentale et Clinique (IREC), Université Catholique de Louvain , Brussels , Belgium.|d Gynecology Department , Cliniques Universitaires Saint Luc , Brussels , Belgium.
authors.forename: Marie-Madeleine
authors.initials: MM
authors.lastname: Dolmans
mesh_terms: D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy* / Q000473:pathology; D009649:Norpregnadienes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D011980:Receptors, Progesterone / Q000187:drug effects / Q000378:metabolism; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D009649:Norpregnadienes; D011980:Receptors, Progesterone; C555622:ulipristal acetate
keywords: PAECs (progesterone receptor modulator-associated endometrial changes); Uterine fibroids; safety; selective progesterone receptors modulators; ulipristal acetate