Testosterone undecanoate therapy for 30 weeks improves sexual function in men with type 2 diabetes and severe hypogonadism (HG), British researchers concluded.
Geoffrey Hackett, MD, of Good Hope Hospital, Sutton Coldfield, West Midlands, UK, and colleagues randomly assigned 199 men with type 2 diabetes and either mild or severe hypogonadism to receive testosterone undecanoate (92 patients) or placebo (107 patients). Of these men, 189 completed the 30-week study. Investigators stratified them, by baseline total testosterone (TT) or free testosterone (FT), into mild HG (TT 9.1–12 nmol/L or FT 0.18–0.25 nmol/L) and severe HG (TT 8 nmol/L or less and FT 0.18 nmol/L or less) groups. They also stratified the men by intervention (placebo or testosterone undecanoate).
Dr Hackett's group observed significant improvement in erectile function—as measured using the 15-item International Index of Erectile Function (IIEF)—only in the severe HG group after 30 weeks of treatment with testosterone undecanoate, according to an online report in BJU International. The IIEF score in these patients rose from 9.1 at baseline to 13.0 at 30 weeks.
Intercourse satisfaction and sexual desire scores in the severe HG group were improved at 6, 18, and 30 weeks, the investigators reported. Testosterone undecanoate did not change orgasmic function in any of the patient groups.
The authors concluded that their study endorses the view of the Endocrine Society that the burden of hypogonadism-related sexual dysfunction in men is evident at TT levels of 8 nmol/L or less.
The present findings also suggest that therapeutic trials of testosterone replacement therapy, especially with testosterone undecanoate, should be more than 30 weeks' duration, not 3 months as suggested by some guidelines, the researchers wrote.
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