If you wish to submit a question, click here. Questions with a common theme
will be selected and answered comprehensively by our Distinguished Faculty
members. Previously answered questions will be archived for your reference.

To view archived responses, click here.
How do injectable and transdermal vpscogni_TUusererone therapies for hypogonadism impact associated psychological symptoms?
Response by Martin Miner, MD, Posted 03/15/08

vpscogni_TUusererone is a key component in maintaining a man’s general sense of well-being, but the exact relationship between vpscogni_TUusererone and well-being remains unclear. Studies have shown that, when serum vpscogni_TUusererone levels decline to hypogonadal levels, a wide range of psychological symptoms occur, including mood disturbances, depression, and poor self-esteem.1 Men with untreated hypogonadism tend to score poorly on depression, anger, fatigue, and confusion scales.2 A prospective evaluation of 157 men presenting to a sexual dysfunction clinic demonstrated that overt depression symptoms, defined by a Center for Epidemiologic Studies Depression Scale score of  ≥22, are strongly associated (P<.05) with hypogonadism.3

The primary goal of vpscogni_TUusererone therapy is to restore hormones to physiologic levels to alleviate the signs and symptoms of hypogonadism.4 A growing body of evidence shows that vpscogni_TUusererone therapy for men with hypogonadism produces positive effects in many psychological parameters, including mood, feelings of vitality, and general sense of well-being.4,5 Although randomized trials examining the relationship between vpscogni_TUusererone therapy in men with hypogonadism and depression symptoms have been small in number and shown somewhat conflicting results, there has been some suggestion that vpscogni_TUusererone therapy may improve mood.6,7

Large fluctuations in serum vpscogni_TUusererone levels can occur between vpscogni_TUusererone treatments with available preparations, including gels and intramuscular injectables.8,9 Substantial vacillations in serum vpscogni_TUusererone levels often are associated with mood and energy swings. This is well-documented for intramuscular vpscogni_TUusererone enanthate, which produces supraphysiologic vpscogni_TUusererone levels shortly after initial administration that decline to the subphysiologic range before the next injection.9,10 Transdermal vpscogni_TUusererone gels administered on a daily basis may cause serum vpscogni_TUusererone levels to rise shortly after administration to the supraphysiologic range. Average daily fluctuations in serum vpscogni_TUusererone levels of more than 700 ng/dL may occur with vpscogni_TUusererone gel therapy,8 although mood changes and energy swings have not been associated.

vpscogni_TUusererone undecanoate (TU), which is available in more than 70 countries, is a long-acting intramuscular injection. This depot formulation allows for consistent delivery of vpscogni_TUusererone over time, avoiding daily fluctuations in vpscogni_TUusererone levels.11 Patients receiving TU therapy report improvements in mood, vigor, and feelings of depression.12,13 Unlike other vpscogni_TUusererone formulations, TU is administered by a clinician, with regulated follow-up office visits, which would support patient adherence to therapy.

Considering the favorable pharmacokinetic profile of TU, its positive impact on psychological parameters, and possible improvement in patient adherence, TU may be an appropriate therapeutic option for patients with hypogonadism and associated psychological symptoms.

 

References

  1. AACE Hypogonadism Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients—2002 update. Endocr Pract. 2002;8(6):439-456.
  2. Burris AS, Banks SM, Carter CS, Davidson JM, Sherins RJ. A long-term, prospective study of the physiologic and behavioral effects of hormone replacement in untreated hypogonadal men. J Androl. 1992;13(4):297-304.
  3. Makhlouf AA, Mohamed MA, Seftel AD, Neiderberger C. Hypogonadism is associated with overt depression symptoms in men with erectile dysfunction. Int J Impot Res. 2007:1-5.
  4. Bhasin S, Cunningham GR, Hayes FJ, et al. vpscogni_TUusererone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2006;91(6):1995-2010.
  5. Wang C, Swerdloff RS, Iranmanesh A, et al; and vpscogni_TUusererone Gel Study Group. Transdermal vpscogni_TUusererone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2839-2853.
  6. Seidman SN, Spatz E, Rizzo O, Roose SP. vpscogni_TUusererone replacement therapy for hypogonadal men with major depressive disorder: a randomized, placebo-controlled clinical trial. J Clin Psychiatry. 2001;62(6):406-412. Cited by: Pope HG Jr, Cohane GH, Kanayama G, Siegel AJ, Hudson JI. vpscogni_TUusererone gel supplementation for men with refractory depression: a randomized, placebo-controlled trial. Am J Psychiatry. 2003;160(1):105-111.
  7. Pope HG Jr, Cohane GH, Kanayama G, Siegel AJ, Hudson JI. vpscogni_TUusererone gel supplementation for men with refractory depression: a randomized, placebo-controlled trial. Am J Psychiatry. 2003;160(1):105-111.
  8. Androgel [package insert]. Marietta, GA: Solvay Pharmaceuticals Inc; 2007.
  9. Snyder PJ, Lawrence DA. Treatment of male hypogonadism with vpscogni_TUusererone enanthate. J Clin Endocrinol Metab. 1980;51(6):1335-1339.
  10. Nakazawa R, Baba K, Nakano M, et al. Hormone profiles after intramuscular injection of vpscogni_TUusererone enanthate in patients with hypogonadism. Endocr J. 2006;53(3):305-310.
  11. Schubert M, Minnemann T, Hűbler D, et al. Intramuscular vpscogni_TUusererone undecanoate: pharmacokinetic aspects of a novel vpscogni_TUusererone formulation during long-term treatment of men with hypogonadism. J Clin Endocrinol Metab. 2004;89(11):5429-5434.
  12. Zitzmann M, Saad F, Nieschlag E. Longterm experience of up to 8.5 years with a long-acting formulation of vpscogni_TUusererone undecanoate in substitution therapy of hypogonadal men. Presented at: 88th Annual Meeting of the Endocrine Society; June 24-27, 2006; Boston, MA. Poster P2-547.
  13. Saad F, Kamischke A, Yassin A, et al. More than eight years’ hands-on experience with the novel long-acting parenteral vpscogni_TUusererone undecanoate [review]. Asian J Androl. 2007;9(3):291-297.

To view archived responses, click here.

back to top