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Clinical Studies and Practice

Symptomatic response to testosterone treatment in dieting obese men with low testosterone levels in a randomized, placebo-controlled clinical trial

Abstract

Background:

Obese men commonly have reductions in circulating testosterone and report symptoms consistent with androgen deficiency. We hypothesized that testosterone treatment improves constitutional and sexual symptoms over and above the effects of weight loss alone.

Methods:

We conducted a pre-specified analysis of a randomized double-blind, placebo-controlled trial at a tertiary referral center. About 100 obese men (body mass index (BMI)30 kg m2) with a repeated total testosterone level 12 nmol l−1 and a median age of 53 years (interquartile range 47–60) receiving 10 weeks of a very-low-energy diet (VLED) followed by 46 weeks of weight maintenance were randomly assigned at baseline to 56 weeks of intramuscular testosterone undecanoate (n=49, cases) or matching placebo (n=51, controls). Pre-specified outcomes were the between-group differences in Aging Male Symptoms scale (AMS) and international index of erectile function (IIEF-5) questionnaires.

Results:

Eighty-two men completed the study. At study end, cases showed significant symptomatic improvement in AMS score, compared with controls, and improvement was more marked in men with more severe baseline symptoms (mean adjusted difference (MAD) per unit of change in AMS score −0.34 (95% confidence interval (CI) −0.65, −0.02), P=0.04). This corresponds to improvements of 11% and 20% from baseline scores of 40 and 60, respectively, with higher scores denoting more severe symptoms. Men with erectile dysfunction (IIEF-520) had improved erectile function with testosterone treatment. Cases and controls lost the same weight after VLED (testosterone −12.0 kg; placebo −13.5 kg, P=0.40) and maintained this at study end (testosterone −11.4 kg; placebo −10.9 kg, P=0.80). The improvement in AMS following VLED was not different between the groups (−0.05 (95% CI −0.28, 0.17), P=0.65).

Conclusions:

In otherwise healthy obese men with mild to moderate symptoms and modest reductions in testosterone levels, testosterone treatment improved androgen deficiency symptoms over and above the improvement associated with weight loss alone, and more severely symptomatic men achieved a greater benefit.

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Acknowledgements

MNTF was supported by a postgraduate scholarship (1055305) and MG by a Career Development Fellowship (1024139) both from the National Health and Medical Research Council (Australia). We are most grateful to Professor David Handelsman and Ms Reena Desai (ANZAC Research Institute, University of Sydney, Australia) for performing the LCMS/MS assay measurements and to Mrs Jenny Healy for assistance with the data collection. Drs Grossmann and Ng Tang Fui had full access to all the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. Bayer Pharma AG (Berlin, Germany) provided testosterone, placebo and financial support to conduct investigations, but had no role in trial design, data analysis or writing the manuscript.

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Correspondence to M Grossmann.

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Competing interests

MG has received research funding from Bayer Pharma, Novartis, Weight Watchers, Lilly and speaker’s honoraria from Besins Healthcare. MNTF has received research funding from Bayer Pharma. The remaining authors declare no conflict of interest.

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Ng Tang Fui, M., Hoermann, R., Prendergast, L. et al. Symptomatic response to testosterone treatment in dieting obese men with low testosterone levels in a randomized, placebo-controlled clinical trial. Int J Obes 41, 420–426 (2017). https://doi.org/10.1038/ijo.2016.242

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