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Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature

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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.

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Author contributions

Protocol/project development Angioni S, Melis GB. Data collection or management Pontis A, Nappi L. Data analysis Pontis A, Paoletti AM. Manuscript writing Pontis A, Sorrentino F.

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Authors and Affiliations

  1. Division of Gynecology and Obstetric, Hospital San Francesco, Nuoro, Italy

    Pontis Alessandro

  2. Department of Medical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, Foggia, Italy

    Nappi Luigi & Sorrentino Felice

  3. Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Cagliari, Italy

    Paoletti Anna Maria, Melis Gian Benedetto & Angioni Stefano

Authors
  1. Pontis Alessandro
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  2. Nappi Luigi
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  3. Sorrentino Felice
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  4. Paoletti Anna Maria
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  5. Melis Gian Benedetto
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  6. Angioni Stefano
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Correspondence to Pontis Alessandro.

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This article does not contain any studies with human participants or animals part performed by any of the authors.

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Alessandro, P., Luigi, N., Felice, S. et al. Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature. Arch Gynecol Obstet 295, 827–832 (2017). https://doi.org/10.1007/s00404-017-4328-6

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  • DOI: https://doi.org/10.1007/s00404-017-4328-6

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