Testosterone undecanoate improves sexual function in men with type 2 diabetes and severe hypogonadism: results from a 30‐week randomized placebo‐controlled study

Abstract

ObjectiveTo evaluate the sexual function response to 30 weeks' treatment with long-acting testosterone undecanoate (TU) or placebo in 199 men with type 2 diabetes and either severe or mild hypogonadism (HG). Patients and MethodsMen with HG were identified from seven primary care type 2 diabetes registers. A 30-week randomized placebo-controlled study of TU was carried out in 199 of these men (placebo, n = 107, TU, n = 92). The patient-reported outcome measure was the 15-item International Index of Erectile Function score. Men completing the study (n=189) were stratified, firstly, by baseline total testosterone (TT) or free testosterone (FT) into mild HG (TT 8.1-12 nmol/L or FT 0.18-0.25 nmol/L) and severe HG groups (TT ≤8 nmol/L and FT ≤0.18 nmol/L), and secondly, by intervention (placebo or TU), thereby creating four groups: mild HG/placebo; mild HG/TU; severe HG/placebo and severe HG/TU. Statistical AnalysisChanges in sexual function score (a secondary outcome of the study) at each visit within group (from baseline) and between groups (TU vs placebo) at each assessment (6, 18 and 30 weeks) were compared using a Wilcoxon signed-rank and Wilcoxon rank-sum test, respectively. ResultsSignificant improvement in erectile function was evident only in the severe HG group after 30 weeks of TU treatment; this finding persisted when TU was compared with placebo. Intercourse satisfaction and sexual desire scores were also improved at 6, 18 and 30 weeks in the severe HG group after TU treatment; this increase in scores was also evident when compared with placebo. TU did not appear to alter orgasmic function significantly in any of the patient groups. ConclusionsThe present study suggests that benefit in sexual symptoms after TU treatment is evident principally in patients with HG with TT levels ≤8 nmol/L and FT levels ≤0.18 nmol/L. We also suggest that 30 weeks of treatment is necessary before evaluating improvement in erectile function.

Testosterone a key factor in gender related metabolic syndrome

“…Thus, if insulin resistance is not evident, no conclusion can be drawn . The administration of testosterone in type‐2 diabetic subjects appears to be ineffective when the symptoms are modest , Hackett et al showed better symptom improvements in men with more severe hypogonadism. The mechanism by which testosterone regulates insulin activity and glycaemic control in men and women is complex and is not completely understood (Fig.…”

The association of sex hormone‐binding globulin with mortality is mediated by age and testosterone in men with type 2 diabetes

“…HG is characterized by low serum testosterone (TT) and sexual dysfunction (Kapoor et al, 2007;Hackett et al, 2009) with both these factors being independent determinants of mortality (Pye et al, 2014). Importantly, testosterone replacement therapy (TRT) has wide-ranging beneficial effects; for example, Hackett et al (2016aHackett et al ( , 2017a and Corona et al (2017) reported improvement in erectile function, sexual desire, and other sexual parameters. Importantly, testosterone replacement therapy (TRT) has wide-ranging beneficial effects; for example, Hackett et al (2016aHackett et al ( , 2017a and Corona et al (2017) reported improvement in erectile function, sexual desire, and other sexual parameters.…”

Statin, testosterone and phosphodiesterase 5-inhibitor treatments and age related mortality in diabetes

“…Three studies, two in men with T2DM, suggest TRT reduces all-cause mortality[17-19]. A randomized controlled study of men with T2DM showed TRT improves symptoms of hypogonadism, the different symptoms significantly improving at varying testosterone thresholds[20]. Importantly, in T2DM patients, erectile dysfunction (ED) appears to be an independent predictor of vascular disease and mortality[13-15].…”