Pontis Alessandro1, Nappi Luigi2, Sorrentino Felice2, Paoletti Anna Maria3, Melis Gian Benedetto3, Angioni Stefano3. 1. Division of Gynecology and Obstetric, Hospital San Francesco, Nuoro, Italy. alesspontis@msn.com. 2. Department of Medical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, Foggia, Italy. 3. Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy.
Abstract
PURPOSE: 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. CONCLUSION: 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.
PURPOSE: 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. CONCLUSION: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: Faik Tatli; Orhan Gozeneli; Hacer Uyanikoglu; Ali Uzunkoy; Huseyin Cahit Yalcın; Abdullah Ozgonul; Osman Bardakci; Adnan Incebiyik; Muhammet Emin Guldur Journal: Bosn J Basic Med Sci Date: 2018-08-01 Impact factor: 3.363
Authors: Ryan D Kilpatrick; Stephanie E Chiuve; William D Leslie; Lani R Wegrzyn; Wei Gao; Hongbo Yang; Ahmed M Soliman; Michael C Snabes; Sarah Koenigsberg; Jia Zhong; Cheryl Xiang; Nelson B Watts Journal: JBMR Plus Date: 2020-11-07