Effect of testosterone treatment on constitutional and sexual symptoms in men
with type 2 diabetes in a randomized, placebo-controlled clinical trial.
Author(s): Gianatti EJ(1), Dupuis P, Hoermann R, Zajac JD, Grossmann M.
Affiliation(s): Author information:
(1)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.
Publication date & source: 2014, J Clin Endocrinol Metab. , 99(10):3821-8
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).
DESIGN: This was a randomized double-blind, parallel, placebo-controlled trial.
SETTING: The study was conducted at a tertiary referral center.
PATIENTS: 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.
INTERVENTION: Eighty-eight participants were randomly assigned to 40 weeks of im
T undecanoate (n = 45) or matching placebo (n = 43).
MAIN OUTCOME MEASURES: 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.
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