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Randomized Controlled Trial
. 2025 Jun 17;110(7):e2157-e2170.
doi: 10.1210/clinem/dgaf060.

Testosterone Treatment and Sexual Function in Men: Secondary Analysis of the T4DM (Testosterone for Diabetes) Trial

Gary A Wittert  1   2 , Kristy P Robledo  3 , David J Handelsman  4 , Warrick J Inder  5 , Bronwyn G A Stuckey  6 , Bu B Yeap  7 , Karen Bracken  8 , Carolyn A Allan  9 , David Jesudason  1   2 , Alicia Jenkins  10 , Andrzej S Januszewski  11 , Mathis Grossmann  12
Affiliations
Randomized Controlled Trial

Testosterone Treatment and Sexual Function in Men: Secondary Analysis of the T4DM (Testosterone for Diabetes) Trial

Gary A Wittert et al. J Clin Endocrinol Metab. .

Erratum in

Abstract

Context: The combined effects of testosterone treatment and lifestyle intervention on sexual function in men at high risk of type 2 diabetes are unclear.

Objective: To assess the effect of testosterone treatment with a lifestyle intervention in men aged 50 to 74 years at high risk of, or newly diagnosed with, type 2 diabetes (via oral glucose tolerance test).

Design: A secondary analysis of the Testosterone for the Prevention of Type 2 Diabetes trial, a double-blind, placebo-controlled trial conducted across 6 Australian centers.

Interventions: Intramuscular testosterone undecanoate (1000 mg) or placebo, 3 monthly for 2 years alongside a community-based lifestyle program.

Main outcomes: Sexual function measured using the International Index of Erectile Function (IIEF)-15 questionnaire.

Results: Of 1007 participants, 792 (79%) had complete International Index of Erectile Function-15 data. Baseline domain scores were inversely related to age and waist circumference, but unrelated to serum testosterone or estradiol levels. Testosterone treatment improved all 5 International Index of Erectile Function-15 domain scores, with stronger effects on sexual desire and orgasmic function in older men, and sexual desire in men with higher depression scores. Testosterone had no impact on depression. Independent of treatment, reductions in waist circumference were associated with improved erectile function, and reductions in depression scores correlated with better sexual function. Clinically significant improvement in erectile function and sexual desire occurred in 3% and 10% of men, respectively, and was inversely related to baseline function. Clinically significant improvement improvements in erectile function and sexual desire were greater in younger and older men respectively.

Conclusion: Testosterone treatment enhanced sexual desire and, to a lesser extent, erectile function, particularly in older men and those with higher waist circumference or depressive symptoms. Reduced waist circumference and depression independently improved sexual function.

Keywords: clinical trial; diabetes; obesity; sexual function; testosterone.

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Figures

Figure 1.
Figure 1.
Unadjusted means by treatment over visits for each IIEF domain.
Figure 2.
Figure 2.
Adjusted mean sexual desire and orgasmic function domains, showing the interaction between age and treatment. Models are adjusted for visit, baseline domain score, and other baseline risk factors.
Figure 3.
Figure 3.
Adjusted mean erectile function and sexual desire domains, showing there is no evidence of an interaction between waist circumference and treatment (both P > .23).
Figure 4.
Figure 4.
Adjusted mean sexual desire score, after accounting for depression scores on-study and the interaction between depression scores and treatment (P = .026).
See this image and copyright information in PMC

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