Long-term treatment with an oral testosterone undecanoate (TU) formulation improves clinical outcomes in men with hypogonadism with no serious safety concerns, a study has shown.

A team of investigators enrolled a total of 129 hypogonadal men (mean age 56.2 years, 87.2 percent White) who completed a 12-month, open-label, multicentre, randomized, active-controlled trial in a 12-month extension study.

To assess the efficacy of oral TU, the investigators measured total serum testosterone concentrations. They also measured sexual function using the Psychosexual Daily Questionnaire (PDQ). In terms of safety, they measured liver function tests, cardiovascular endpoints, and prostate health.

Total serum testosterone concentrations over 2 years for patients who received oral TU were in the eugonadal range (300‒1,000 ng/dL; mean 617 ng/dL) and significantly increased from baseline (p<0.0001). Mean score changes of sexual function for all PDQ domains also improved at all time points compared with baseline (p<0.0011 for all).

Patients’ scores for sexual activity and sexual desire components were consistently higher than validated thresholds for clinically meaningful change.

Furthermore, typical testosterone-induced safety changes occurred, such as a 3‒6 mm Hg increase in systolic blood pressure (p<0.05), a slight increase in haematocrit (p<0.0001) that stayed <48 percent throughout the study, and a lower high-density lipoprotein cholesterol (‒9.8 mg/dL from baseline; p<0.0001); there were no significant changes in prostate-specific antigen levels.

For liver function tests, no clinically significant changes from baseline were observed.

“Over 2 years of treatment, this novel oral TU formulation maintained total testosterone concentrations in mideugonadal ranges, with improvements in sexual function and no clinically significant changes in liver function or other safety concerns previously associated with oral testosterone replacement therapy,” the investigators said.