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Combined testosterone therapy, weight loss improves androgen deficiency in men with obesity
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In healthy men with obesity and modest reductions in testosterone, combined weight loss and testosterone therapy improved androgen deficiency symptoms beyond any benefits associated with weight loss alone, according to findings from a randomized controlled trial.
Mathis Grossman, MD, PhD, FRACP, associate professor in the department of medicine at the University of Melbourne in Victoria, Australia, and colleagues analyzed data from 100 men with obesity (BMI 30 kg/m²) with a repeated total testosterone level of up to 12 nmol/L assigned to a very low-energy diet for 10 weeks (640 kcal per day), followed by 46 weeks of weight maintenance. Researchers randomly assigned the men to 56 weeks of intramuscular testosterone undecanoate (1,000 mg; n = 49; cases) or matching placebo (n = 51, controls). The study was conducted between April 2013 and November 2015. The primary outcome of the trial was change in fat mass; for this secondary analysis, the prespecified outcomes were the between-group differences in the Aging Males’ Symptoms (AMS) scale and the international index of erectile function questionnaire, both administered at baseline and at 10 and 56 weeks. At baseline, 43% of cases and 41% of controls reported moderate or severe symptoms by AMS score; 13% of cases and controls reported moderate or severe erectile dysfunction.
At study end, total testosterone increased from a mean of 6.8 nmol/L at baseline to a mean of 14.1 nmol/L for cases and from 7 nmol/L at baseline to 10 nmol/L for controls (both P < .05 compared with baseline; P < .001 between groups). In the testosterone group, improvement in symptoms was baseline dependent and increased progressively with worse AMS scores, according to researchers. The mean adjusted difference per unit of change in AMS score was –0.34 (95% CI, –0.65 to –0.02), such that baseline AMS scores of 40 and 60 improved by 11% and 20%, respectively, in men assigned to testosterone therapy. AMS sexual and sexual desire subscores also improved in cases vs. controls, according to researchers.
“Interestingly, this benefit was seen despite the fact that initial rapid weight loss was associated [with] a 20% mean improvement in total AMS score after the 10-week [very low-energy diet] phase, with no difference among participants assigned to testosterone treatment or placebo,” the researchers wrote. “This suggests that while symptomatic improvements associated with weight loss may override the effects of testosterone treatment in the short term, testosterone treatment sustains these symptomatic improvements in the longer term, even if, as in our cohort, weight regain is prevented.”
Grossman said that men with obesity and suggestive clinical features should be screened for testosterone deficiency, and those with pathological hypogonadism should be considered for testosterone replacement.
“However, larger long term clinical studies are needed before testosterone treatment of obese men with lowered testosterone who do not have pituitary or testicular disease can be recommended,” Grossmann told Endocrine Today. “Instead, the clinical approach should focus on weight loss and optimization of comorbidities. If successful, this approach will improve long term health outcomes and will also increase circulating testosterone levels.”
– by Regina Schaffer
Disclosure: Bayer Pharma provided testosterone, placebo and financial support to conduct investigations, but had no role in the trial design or data analysis. Grossmann reports receiving research funding or speaking fees from Bayer Pharma, Besins Healthcare, Eli Lilly, Novartis and Weight Watcher’s; another researcher reports receiving research funding from Bayer.
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