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 m-2) 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-5⩽20) 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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Testosterone treatment improved constitutional symptoms and sexual function over and above the effects of weight loss alone in the same RCT.
“However, testosterone treatment improved constitutional symptoms and sexual function over and above the effects of weight loss alone.101”
From Hypogonadism and male obesity: Focus on unresolved questions (2018) · cites this paper as [101]
The benefits reported with testosterone treatment in this cohort cannot be extended to unselected obese men.
“Therefore, the benefits reported with testosterone treatment in this cohort 91,101 cannot be extended to unselected obese men.”
From Hypogonadism and male obesity: Focus on unresolved questions (2018) · cites this paper as [101]
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- Authors
- Ng Tang Fui, M., Hoermann, R., Prendergast, L. A., Zajac, J. D., & Grossmann, M.
- Affiliations
- The University of Melbourne (AU)
- Corresponding author
- Grossmann, M
- Venue
- International Journal of Obesity
- Published
- 2016-12-28
- Volume
- 41
- Issue
- 3
- Pages
- 420-426
- ISSN
- 0307-0565 (ISSN-L)
- 1476-5497
- OpenAlex
- W2567518804
- Cited by
- 40
- References
- 35
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 2 · 2023: 3 · 2022: 4 · 2021: 2 · 2020: 2 · 2019: 13 · 2018: 7 · 2017: 4
- FWCI
- 8.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Obesity (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone replacement therapy, testosterone undecanoate, androgen deficiency, obesity, men, very low calorie diet, weight loss, aging male symptoms, erectile function, sexual symptoms, weight maintenance
- MeSH terms
- Aging, Androgens, Australia, Depression, Diet, Reducing, Double-Blind Method, Humans, Hypogonadism, Libido, Male, Middle Aged, Obesity, Quality of Life, Testosterone, Treatment Outcome, Hormone Replacement Therapy
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