Testosterone failed to improve sexual symptoms in obesity, type 2 diabetes
Testosterone treatments given to aging men with obesity, type 2 diabetes and already lowered circulating levels of the hormone did not improve their constitutional or sexual symptoms, according to research published in The Journal of Clinical Endocrinology & Metabolism.
Emily J. Gianatti, MBBS, PhD, of the University of Melbourne, Heidelberg, Australia, evaluated the effects of testosterone treatment on men aged 35 to 70 years in a randomized, double blind, parallel, placebo-controlled trial at the institution’s Austin Health referral center.
The researchers looked at 88 patients with type 2 diabetes (HbA1c <8.5%; total testosterone <12 nmol/L, or 346 ng/dL) who had mild to moderate aging male symptoms and erectile dysfunction. The men were assigned to testosterone undecanoate (n=45; BMI, 31.5 kg/m2) or matching placebo (n=43; BMI, 33.4 kg/m2), then evaluated for 40 weeks.
The team measured constitutional symptoms using the aging male symptoms (AMS) score, with sexual desire quantified through question 17, and evaluated erectile function through the International Index of Erectile Function-5 (IIEF-5).
During the study, substantial improvements were not seen with treatment compared with placebo for mean adjusted difference in change for aging male symptoms (AMS total score, –0.9; 95% CI, –4.1 to 2.2) or sexual desire (AMS question 17, –0.3; 95% CI, –0.8 to 0.2).
The mean adjusted difference in change for erectile function in men with testosterone was reduced (IIEF-5, –2; 95% CI, –3.4 to –0.6) compared with placebo, but no significant difference in IIEF-5 scores was observed between baseline and 40 weeks if analyzing groups separately.
Men with depression and microvascular complications showed worse symptoms at baseline, but this did not correlate with testosterone levels.
“The negative findings of this trial do not rule out the possibility that testosterone treatment may lead to a symptomatic improvement in aging men with obesity and type 2 diabetes, but make it unlikely that a substantial, clinically meaningful response occurs in such men,” the researchers wrote.
Disclosure: The researchers report fellowships from the National Health and Medical Research Council of Australia, grants from Pfizer Australia and the Royal Australasian College of Physicians/Osteoporosis Australia and a scholarship from the University of Melbourne.