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* This study demonstrated that this novel oral TU safely and effectively increased T levels in hypogonadal men, with patients achieving mean serum T concentrations above 26 nmol/L by day 105. Of note, there were no clinically significant changes from baseline in liver function tests. The range of titratable doses allowed for flexible treatment adjustments based on individual patient responses, providing an effective oral therapeutic option and filling a crucial unmet need in Canada.
Introduction
An estimated 1/4 men in Canada aged 40–62 years have hypogonadism, defined as serum testosterone (T) levels <10.4 nmol/L with symptoms of T deficiency. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral testosterone therapies provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from the phase 3 inTUne study of oral titratable testosterone undecanoate (TU, JATENZO®), which was Health Canada approved in December 2025 and available in 158, 198, 237, 316, and 396 mg doses, with the goal of demonstrating that oralTU doses safely and effectively achieve and maintain normal mean serum T concentration in patients throughout the study. This novel oral TU employs a unique lipid-based, self-emulsifying drug-delivery system (SEDDS), which enables avoidance of first-pass hepatic metabolism and facilitates absorption through the intestinal lymphatic system.
Methods
A phase 3, randomized, active-controlled, open-label study was con- ducted to assess the safety and efficacy of oral TU in 166 hypogonadal men. The initial oral TU dose was 237 mg TU twice a day (BID). Titration opportunities were on days 35 and 70 based on the 24-hour average T concentration on days 21 and 56. Four hours post-dose, T measurements were taken before and after each titration adjustment (days 21, 56, and 105, respectively).
Results
A total of 155 patients had serum T data on all study days. Mean serum T at baseline was 9.0 nmol/L. Patients achieved four-hour post-dose mean serum T concentrations of 21.4, 24.7, and 26.8 nmol/L by say 21, 56, and 105, respectively. By day 105, 40%, 32%, and 26% were on a dose of 396 mg, 316 mg, and 237 mg, respectively, to achieve target T levels. With the starting dose of 237 mg, 92% of men achieved mean serum T >10.4 nmol/Lon day 21; with two titration opportunities, 99% of men achieved mean serum T >10.4 nmol/L.
Conclusions
This study demonstrated that this novel oral TU safely and effectively increased T levels in hypogonadal men, with patients achieving mean serum T concentrations above 26 nmol/L by day 105. Of note, there were no clinically significant changes from baseline in liver function tests. The range of titratable doses allowed for flexible treatment adjustments based on individual patient responses, providing an effective oral therapeutic option and filling a crucial unmet need in Canada.
Introduction
An estimated 1/4 men in Canada aged 40–62 years have hypogonadism, defined as serum testosterone (T) levels <10.4 nmol/L with symptoms of T deficiency. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral testosterone therapies provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from the phase 3 inTUne study of oral titratable testosterone undecanoate (TU, JATENZO®), which was Health Canada approved in December 2025 and available in 158, 198, 237, 316, and 396 mg doses, with the goal of demonstrating that oralTU doses safely and effectively achieve and maintain normal mean serum T concentration in patients throughout the study. This novel oral TU employs a unique lipid-based, self-emulsifying drug-delivery system (SEDDS), which enables avoidance of first-pass hepatic metabolism and facilitates absorption through the intestinal lymphatic system.
Methods
A phase 3, randomized, active-controlled, open-label study was con- ducted to assess the safety and efficacy of oral TU in 166 hypogonadal men. The initial oral TU dose was 237 mg TU twice a day (BID). Titration opportunities were on days 35 and 70 based on the 24-hour average T concentration on days 21 and 56. Four hours post-dose, T measurements were taken before and after each titration adjustment (days 21, 56, and 105, respectively).
Results
A total of 155 patients had serum T data on all study days. Mean serum T at baseline was 9.0 nmol/L. Patients achieved four-hour post-dose mean serum T concentrations of 21.4, 24.7, and 26.8 nmol/L by say 21, 56, and 105, respectively. By day 105, 40%, 32%, and 26% were on a dose of 396 mg, 316 mg, and 237 mg, respectively, to achieve target T levels. With the starting dose of 237 mg, 92% of men achieved mean serum T >10.4 nmol/Lon day 21; with two titration opportunities, 99% of men achieved mean serum T >10.4 nmol/L.
Conclusions
This study demonstrated that this novel oral TU safely and effectively increased T levels in hypogonadal men, with patients achieving mean serum T concentrations above 26 nmol/L by day 105. Of note, there were no clinically significant changes from baseline in liver function tests. The range of titratable doses allowed for flexible treatment adjustments based on individual patient responses, providing an effective oral therapeutic option and filling a crucial unmet need in Canada.
