Optimal injection interval for testosterone undecanoate treatment of hypogonadal and transgender men

Objective: To define the optimized inter-injection interval of injectable testosterone undecanoate (TU) treatment for hypogonadal and transmen based o n individual dose titration in routine clinical practice. Design and methods: A prolective observational study of consecutive TU injections in men undergoing testosterone replacement therapy for pathological hypogonadism or masculinization of female-to-male transgender (transmen) subject to individual dosing titration to achieve a stable replacement regimen. Results: From 2006 to 2019, 6899 injections were given to 325 consecuti ve patients. After excluding the 6-week loading dose, 6300 injections were given t o 297 patients who had at least three and a median of 14 injections. The optimal injec tion interval (mean of last three injection intervals) had a median of 12.0 weeks (int erquartile range 10.4–12.7 weeks). The interval was significantly influenced by ag e and body size (body surface area, BSA) but not by diagnosis or trough serum LH, FSH , and SHBG. Longer (≥14 weeks; 68/297, 23%), but not shorter (≤10 weeks; 22/297, 7.4%), intervals were weakly correlated with age but not diagnosis or other cova riables. Low blood hemoglobin increased with trough serum testosterone to reach pl ateau once testosterone was about 10 nmol/L or higher. Conclusion: Optimal intervals between TU injection after individual titrat ion resulted in the approved 12-week interval in 70% of patients with only m inor influence for clinical application of BSA and not of trough serum LH, FSH, an d SHBG. Individually optimized inter-injection interval did not differ between men wi th primary or secondary hypogonadism or transmen.