The Journal of Urology
Volume 180, Issue 6 , Pages 2307-2313 , December 2008

Long Acting Testosterone Undecanoate Therapy in Men With Hypogonadism: Results of a Pharmacokinetic Clinical Study

Presented at annual meeting of American Urological Association, Orlando, Florida, May 20, 2008.

  • Abraham Morgentaler

      Affiliations

    • Men's Health Boston, Brookline, Massachusetts
    • Corresponding Author InformationCorrespondence: Men's Health Boston, One Brookline Pl., Suite 624, Brookline, Massachusetts 02445 (telephone: 617-277-5000; FAX: 617-277-5444)
    • Financial interest and/or other relationship with Indevus, Solvay, Auxilium and Watson.
    • ,
  • Adrian S. Dobs

      Affiliations

    • Financial interest and/or other relationship with Ardana, Indevus and ProStrakan.
    • Department of Medicine and Oncology, Endocrinology and Metabolism, Johns Hopkins University, Baltimore, Maryland
    • ,
  • Joel M. Kaufman

      Affiliations

    • Financial interest and/or other relationship with Indevus, Lilly, Novartis, Astellas/GlaxoSmithKline and Coloplast.
    • Advanced Urology, P.C. and Department of Urology and Genitourinary Surgery, Aurora, Colorado
    • ,
  • Martin M. Miner

      Affiliations

    • Financial interest and/or other relationship with Sanofi-Aventis, Indevus, GlaxoSmithKline and Auxilium.
    • Department of Family Medicine, Alpert School of Medicine, Brown University and Miriam Hospital, Providence, Rhode Island
    • ,
  • Ridwan Shabsigh

      Affiliations

    • Financial interest and/or other relationship with Indevus, Pfizer, Bayer Schering Plough, American Medical Systems and Auxilium.
    • Division of Urology, Maimonides Medical Center, Brooklyn, New York
    • ,
  • Ronald S. Swerdloff

      Affiliations

    • Division of Endocrinology, LABioMedical Research Institute at Harbor-University of California-Los Angeles Medical Center, Torrance, California
    • Department of Medicine, David Geffen School of Medicine at University of California-Los Angeles, Torrance, California
    • ,
  • Christina Wang

      Affiliations

    • Financial interest and/or other relationship with Indevus, Clarus, Acrux, BMS and Met P.
    • General Clinical Research Center, LABioMedical Research Institute at Harbor-University of California-Los Angeles Medical Center, Torrance, California
    • Department of Medicine, David Geffen School of Medicine at University of California-Los Angeles, Torrance, California

Received 24 June 2008

References 

  1. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients—2002 update. AACE Hypogonadism Task Force. Endocr Pract. 2002;8:439
  2. Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2006;91:1995
  3. Skin Patch Replaces Testosterone (United States Food and Drug Administration). http://www.fda.gov/fdac/departs/196_upd.htmlAccessed January 22, 2008
  4. Seftel A. Testosterone replacement therapy for male hypogonadism, part III: pharmacologic and clinical profiles, monitoring, safety issues, and potential future agents. Int J Impot Res. 2007;19:2
  5. Hong BS, Ahn TY. Recent trends in the treatment of testosterone deficiency syndrome. Int J Urol. 2007;14:981
  6. Nieschlag E. Testosterone treatment comes of age: new options for hypogonadal men. Clin Endocrinol (Oxf). 2006;65:275
  7. Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab. 2004;89:2085
  8. Schubert M, Minnemann T, Hübler D, Rouskova D, Oettel CM, Ernst M, et al. Intramuscular testosterone undecanoate: pharmacokinetic aspects of a novel testosterone formulation during long-term treatment of men with hypogonadism. J Clin Endocrinol Metab. 2004;89:5429
  9. Zhang GY, Gu YQ, Wang XH, Cui YG, Bremner WJ. A pharmacokinetic study of injectable testosterone undecanoate in hypogonadal men. J Androl. 1998;19:761
  10. VonEckardstein S, Nieschlag E. Treatment of male hypogonadism with testosterone undecanoate injected at extended intervals of 12 weeks: a phase II study. J Androl. 2002;23:419
  11. Mackey MA, Conway AJ, Handelsman DJ. Tolerability of intramuscular injections of testosterone ester in oil vehicle. Hum Reprod. 1995;10:862
  12. Jordan WP. Allergy and topical irritation associated with transdermal testosterone administration: a comparison of scrotal and nonscrotal transdermal systems. Am J Contact Dermat. 1997;8:108
  13. Testosterone and Aging: Clinical Research Directions (Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy). Washington, D. C: National Academies Press; 2004;Available at http://www.nap.edu/catalog.php?record_id=10852. Accessed July 30, 2008

 Study received institutional review board approval.

PII: S0022-5347(08)02418-X

doi: 10.1016/j.juro.2008.08.126

The Journal of Urology
Volume 180, Issue 6 , Pages 2307-2313 , December 2008

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