11 November 2013 Subscribe to our news feed
Testosterone undecanoate can improve sexual function and quality of life in males with type 2 diabetes

Testosterone replacement therapy with long-acting testosterone undecanoate improves sexual function and quality-of-life parameters vs. placebo in a population of men with type 2 diabetes. Hackett G, Cole N, Bhartia M, et al. J Sex Med 2013; 10(6):1612-1617.
This editorial discusses the key findings and implications of a study published in 2013 by Hackett et al.1 (The BLAST study) that investigated the effect of testosterone replacement therapy on sexual function and quality of life parameters versus placebo in males with type 2 diabetes (T2D). The study was separated into two phases. The first phase was a 30-week, prospective, randomized, double-blind, placebo-controlled multicenter study conducted between September 2008 and June 2011 at eight UK Midland centers. A total of 190 males (age >18 years) with T2D received long-acting Testosterone Undecanoate (TU) 1000 mg or placebo for 30 weeks (at weeks 0, 6, and 18). The second phase was a 52-week follow-on with open-label TU therapy in 96 patients proceeding from the first phase. The primary outcome of the study was a statistically significant change from baseline in the 15-item International Index of Erectile Function (IIEF) domains. Notable secondary outcomes included health-related quality-of-life symptoms, as measured by the 17-item Ageing Male Symptom Scale (AMS) questionnaire.
Key Points
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What is known
What these studies add
The results from the BLAST study confirm the beneficial effects of TU on IIEF domains and health-related quality of life in males with T2D, and complement previously published data.10,11 However, data from this 82-week study illustrate the effect of depression on the response to testosterone replacement therapy; with baseline depression diminishing any response to sexual function altogether. Adding to this, a significant reduction in AMS was observed only in patients without depression. Depression has been shown to independently impact sexual function, as well as reduce diabetes medication response and adherence, which should be considered during treatment decisions.12-14
The addition of a subgroup of males taking PDE5Is is novel, as similar studies investigating testosterone replacement therapy in diabetic males fail to identify whether PDE5Is were excluded.15-17 Males with T2D within this subgroup showed no improvement in IIEF domains during the double-blind phase, but showed large improvements after a further 12 months of open-label treatment. This delayed improvement may be explained through the achievement of sustained levels of TU beyond ≥5 injections, and the long 54-day half-life of long-acting TU. This is of clinical importance, as current guidelines recommend only 3 to 6 months of testosterone replacement therapy and the duration of TU therapy in previously published studies may have been too short for benefits in sexual function to present. As a result, males with T2D should be screened for low testosterone levels and depression, and considered for testosterone replacement therapy beyond the 6 months currently recommended.

References
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3. Isidori A, Giannetta E, Gianfrilli D, et al. Effects of testosterone on sexual function in men: results of a meta-analysis. Clin Endocrinol (Oxf) 2005;63(4):381-394.
4. Hackett G, Cole N, Deshpande A, et al. Biochemical hypogonadism in men with type 2 diabetes in primary care practice. Br J Diabetes Vasc Dis 2009;9:226-231.
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10. Khera M, Bhattacharya R, Blick G, et al. Improved sexual function with testosterone replacement therapy in hypogonadal men: real-world data from the Testim Registry in the United States (TRiUS). J Sex Med 2011;8(11):3204-3213.
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12. Dinan TG. Inflammatory markers in depression. Curr Opin Psychiatry 2009;22(1):32-36.
13. Papelbaum M, Moreira RO, Coutinho W, et al. Depression, glycemic control and type 2 diabetes. Diabetol Metab Syndr 2011;3(1):26.
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15. Giltay E, Tishova Y, Mskhalaya G, et al. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med 2010;7(7):2572-2582.
16. Kalinchenko SY, Tishova YA, Mskhalaya GJ, et al. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf) 2010;73(5):602-612.
17. Jones T, Arver S, Behre H, et al. Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study). Diabetes Care 2011;34(4):828-837.
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