The Journal of Urology
Volume 180, Issue 5 , Pages 1986-1992 , November 2008

A 1-Year, Open Label, Randomized Phase II Dose Finding Study of Degarelix for the Treatment of Prostate Cancer in North America

  • Marc Gittelman

      Affiliations

    • Department of Urology, South Florida Medical Research, Aventura, Florida
    • Corresponding Author InformationCorrespondence: 21150 Biscayne Blvd. Suite #300, Aventura, Florida 33180 (telephone: 305-931-8080; FAX: 305-391-8088)
    • ,
  • Peter J. Pommerville

      Affiliations

    • Department of Urological Sciences, University of British Columbia, Victoria, British Columbia
    • ,
  • Bo-Eric Persson

      Affiliations

    • Department of Global Marketing, Ferring Pharmaceuticals A/S, Copenhagen, Denmark
    • Financial interest and/or other relationship with Ferring Pharmaceuticals A/S.
    • ,
  • Jens-Kristian Jensen

      Affiliations

    • Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark
    • Financial interest and/or other relationship with Ferring Pharmaceuticals A/S.
    • ,
  • Tine Kold Olesen

      Affiliations

    • Clinical R&D, Ferring Pharmaceuticals A/S, Copenhagen, Denmark
    • Financial interest and/or other relationship with Ferring Pharmaceuticals A/S.
    • ,
  • Degarelix Study Group

Received 6 February 2008

References 

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  4. Heber D, Dodson R, Stoskopf C, Peterson M, Swerdloff RS. Pituitary desensitization and the regulation of pituitary gonadotropin-releasing hormone (GnRH) receptors following chronic administration of a superactive GnRH analog and testosterone. Life Sci. 1982;30:2301
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  8. Tomera K, Gleason D, Gittelman M, Moseley W, Zinner N, Murdoch M, et al. The gonadotropin-releasing hormone antagonist abarelix depot versus luteinizing hormone releasing hormone agonists leuprolide or goserelin: initial results of endocrinological and biochemical efficacies in patients with prostate cancer. J Urol. 2001;165:1585
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  12. Schwach G, Oudry N, Delhomme S, Lück M, Lindner H, Gurny R. Biodegradable microparticles for sustained release of a new GnRH antagonist – part I: screening commercial PLGA and formulation technologies. Eur J Pharm Biopharm. 2003;56:327
  13. Schwach G, Oudry N, Giliberto J-P, Broqua P, Lück M, Lindner H, et al. Biodegradable PLGA microparticles for sustained release of a new GnRH antagonist: part II (In vivo performance). Eur J Pharm Biopharm. 2004;57:441
  14. Koechling W. Effect of various GnRH antagonists on histamine release from human skin. In: Presented at the 8th International Symposium on GnRH Analogues in Cancer and Human Reproduction. Salzburg, Austria. February 10–13, 2005;
  15. Balchen T, Agersø H, Olesen TK, Jensen JK, Senderovitz T. Pharmacokinetics, pharmacodynamics, and safety of a novel fast-acting gonadotropin-releasing hormone receptor blocker, degarelix, in healthy men. In: Presented at the 8th International Symposium on GnRH Analogues in Cancer and Human Reproduction. Salzburg, Austria. February 10–13, 2005;
  16. Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker–results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008;54:805
  17. Weston P, Hammonds J, Vaughton K, Olesen TK, Jensen JK, Eskerod O, et al. Degarelix: a novel GnRH antagonist tested in a multicenter, randomized dose-finding study in prostate cancer patients. BJU Int. 2004;94(suppl.):57
  18. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. (Amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000; notes of clarification issued in 2002 and 2004).
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  20. Koch M, Steidle C, Brosman S, Centeno A, Gaylis F, Campion M. An open-label study of abarelix in men with symptomatic prostate cancer at risk of treatment with LHRH agonists. Urology. 2003;62:877
  21. Zinner NR, Bidair M, Centeno A, Tomera K. Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial. Urology. 2004;64:1177

 Supported by Ferring Pharmaceuticals A/S.

 Study received institutional review board approval.

PII: S0022-5347(08)01836-3

doi: 10.1016/j.juro.2008.07.033

The Journal of Urology
Volume 180, Issue 5 , Pages 1986-1992 , November 2008

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