title: Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature.
abstract: OBJECTIVE
  Limitated studies have reported the efficacy of GnRH antagonist on endometriosis symptoms. The aim of our study was to review all available trials to investigate the medical treatment of endometriosis with only GnRH antagonists, with special attention to pharmacodynamic activity, safety, and efficacy.
  
  
  METHODS
  Pub Med and Sciencedirect database were searched using terms of "endometriosis treatment", "GnRH antagonist", and "Elagolix". The search was limited to clinical studies published in English. Title and abstract were screened to identify relevant articles.
  
  
  RESULTS
  Five studies covering use of GnRH antagonist were found. A phase 1 study evaluated the safety, pharmacokinetics, and inhibitory effects on gonadotropins and estradiol of single dose and 7 day elagolix administration to healthy premenopausal women; two phase II studies evaluated efficacy in patient with endometriosis. Moreover, there are two Phase III clinical trials just completed.
  
  
  CONCLUSIONS
  GnRH antagonists may have the advantage of oral administration and lower incidence of adverse events. Currently, only Phase II studies have been published demonstrating promising results in terms of efficacy, safety, and tolerability. From the results of the phase III studies, elagolix may become a valuable addition to the armamentarium of pharmacological agents to treat endometriosis-related pain.
authors.affiliation: Division of Gynecology and Obstetric, Hospital San Francesco, Nuoro, Italy. alesspontis@msn.com.
authors.forename: Pontis
authors.initials: P
authors.lastname: Alessandro
authors.affiliation: Department of Medical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, Foggia, Italy.
authors.forename: Nappi
authors.initials: N
authors.lastname: Luigi
authors.affiliation: Department of Medical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, Foggia, Italy.
authors.forename: Sorrentino
authors.initials: S
authors.lastname: Felice
authors.affiliation: Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: Paoletti Anna
authors.initials: PA
authors.lastname: Maria
authors.affiliation: Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: Melis Gian
authors.initials: MG
authors.lastname: Benedetto
authors.affiliation: Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: Angioni
authors.initials: A
authors.lastname: Stefano
mesh_terms: D000328:Adult; D004715:Endometriosis / Q000150:complications / Q000188:drug therapy*; D004958:Estradiol / Q000097:blood; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors*; D006062:Gonadotropins / Q000627:therapeutic use; D006727:Hormone Antagonists / Q000627:therapeutic use*; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D017697:Premenopause; D011743:Pyrimidines / Q000627:therapeutic use*; D012106:Research
chemical_list: D006062:Gonadotropins; D006727:Hormone Antagonists; D006845:Hydrocarbons, Fluorinated; D011743:Pyrimidines; D007987:Gonadotropin-Releasing Hormone; D004958:Estradiol; C539351:elagolix
keywords: Elagolix; Endometriosis treatment; GnRH antagonist