Effect of Testosterone Treatment on Constitutional and Sexual Symptoms in Men With Type 2 Diabetes in a Randomized, Placebo-Controlled Clinical Trial
Autor: | Mathis Grossmann, Rudolf Hoermann, Philippe Dupuis, Jeffrey D Zajac, Emily J Gianatti |
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Rok vydání: | 2014 |
Předmět: |
Adult
Male Aging Invited Research Highlight medicine.medical_specialty Hormone Replacement Therapy Constitutional symptoms Libido Endocrinology Diabetes and Metabolism Clinical Biochemistry Type 2 diabetes Placebo Biochemistry law.invention Placebos Endocrinology Double-Blind Method Erectile Dysfunction Randomized controlled trial law Internal medicine Humans Medicine Testosterone Obesity Aged Depression business.industry Biochemistry (medical) Middle Aged medicine.disease Clinical trial Sexual desire Treatment Outcome Erectile dysfunction Diabetes Mellitus Type 2 Androgens business |
Zdroj: | Asian Journal of Andrology |
ISSN: | 1945-7197 0021-972X |
DOI: | 10.1210/jc.2014-1872 |
Popis: | 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. |
Databáze: | OpenAIRE |
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