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Title: Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial.
Austin Authors: Gianatti, Emily J;Dupuis, Philippe;Hoermann, Rudolf;Zajac, Jeffrey D ;Grossmann, Mathis 
Affiliation: 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
Issue Date: 30-Jun-2014
Publication information: The Journal of Clinical Endocrinology and Metabolism 2014; 99(10): 3821-8
Abstract: 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).This was a randomized double-blind, parallel, placebo-controlled trial.The study was conducted at a tertiary referral center.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.Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate (n = 45) or matching placebo (n = 43).Constitutional symptoms using the aging male symptoms (AMS) score, sexual desire (question 17 AMS score), and erectile function (International Index of Erectile Function-5).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.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.
Gov't Doc #: 24978674
DOI: 10.1210/jc.2014-1872
Journal: The Journal of Clinical Endocrinology and Metabolism
Type: Journal Article
Subjects: Adult
Androgens.administration & dosage.adverse effects.blood
Diabetes Mellitus, Type 2.complications
Double-Blind Method
Erectile Dysfunction.drug therapy.etiology
Hormone Replacement Therapy.adverse effects.methods
Libido.drug effects
Middle Aged
Testosterone.administration & dosage.adverse effects.analogs & derivatives.blood
Treatment Outcome
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