title: Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial.
abstract: OBJECTIVE
  The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes (T2D).
  
  
  METHODS
  This was a randomized double-blind, parallel, placebo-controlled trial.
  
  
  METHODS
  The study was conducted at a tertiary referral center.
  
  
  METHODS
  Men aged 35-70 years with T2D, a hemoglobin A1c less than 8.5%, and a total T level less than 12.0 nmol/L (346 ng/dL) with mild to moderate aging male symptoms and erectile dysfunction.
  
  
  METHODS
  Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate (n = 45) or matching placebo (n = 43).
  
  
  METHODS
  Constitutional symptoms using the aging male symptoms (AMS) score, sexual desire (question 17 AMS score), and erectile function (International Index of Erectile Function-5).
  
  
  RESULTS
  T treatment did not substantially improve aging male symptoms [mean adjusted difference (MAD) in change over 40 weeks across the T and placebo groups in AMS total score, -0.9 (95% confidence interval [CI] -4.1, 2.2), P = .67] or sexual desire [MAD in question 17 AMS, -0.3 (95% CI -0.8, 0.2), P = .17]. Although compared with placebo, erectile function in men assigned to T was reduced [MAD in International Index of Erectile Function abridged version 5, -2.0 (95% CI -3.4, -0.6), P < .02], there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately. At baseline, symptoms were worse in men with depression and microvascular complications but did not correlate with T levels.
  
  
  CONCLUSIONS
  In this trial, T treatment did not substantially improve constitutional or sexual symptoms in obese, aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men.
authors: Department of Medicine (E.J.G., P.D., R.H., J.D.Z., M.G.), Austin Health, University of Melbourne, and Endocrine Unit (E.J.G., P.D., J.D.Z., M.G.), Austin Health, Heidelberg 3084, Australia.
authors: Emily J
authors: EJ
authors: Gianatti
authors: Philippe
authors: P
authors: Dupuis
authors: Rudolf
authors: R
authors: Hoermann
authors: Jeffrey D
authors: JD
authors: Zajac
authors: Mathis
authors: M
authors: Grossmann
mesh_terms: D000328:Adult; D000368:Aged; D000375:Aging; D000728:Androgens / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood; D003863:Depression / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D007989:Libido / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D010919:Placebos; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D010919:Placebos; D013739:Testosterone; C010792:testosterone undecanoate