madman
Super Moderator
COMPARISON BETWEEN ORAL TESTOSTERONE UNDECANOATE (JATENZO®) AND A TRANSDERMAL TESTOSTERONE GEL (ANDROGEL® 1%) IN TOTAL TESTOSTERONE, FREE TESTOSTERONE, AND SHBG AFTER ONE YEAR OF THERAPY (2022)
Ronald Swerdloff, Christina Wang, Marc Gittelman, Jed Kaminetsky, John K. Amory, Jay Newmark, Robert Dudley, Lundquist Institute at Harbor-UCLA, Torrance, CA; UroMedix and South Florida Medical Research, Aventura, FL; New York University School of Medicine, New York NY; University of Washington School of Medicine, Seattle, WA; Clarus Therapeutics, Northbrook, IL
Objective: A novel oral testosterone undecanoate formulation (TU, JATENZO) is now available for testosterone (T) replacement therapy (TRT) in appropriate men. The purpose of this analysis was to compare the effects of oral TU to those of a transdermal TRT (T-Gel, AndroGel 1%) on circulating total T, measured free T, and sex-hormone-binding globulin (SHBG) concentrations.
Methods: Hypogonadal men, aged 18-75 y/o, were enrolled in a one-year, open-label, multicenter, dose-titration trial. Subjects were randomized 1:1 between 2 treatment groups: oral TU or T-Gel. Total and free T concentrations were assayed at pre-designated time points. Standard safety measures, including prostate and cardiovascular biomarkers, have been previously described (Swerdloff and Dudley, Ther Adv Urol 2020;12:1-16).
Results: After one year of treatment, total and free T significantly increased in both groups. Total T concentrations went from 209.9 ± 8.52 ng/dL to 524.0 ± 19.1 ng/dL (BL to d365, mean ± SEM) and 218.9 ± 8.20 ng/dL to 424.7 ± 15.51 ng/dL, for the TU and T-Gel groups, respectively. There was a marked decrease in SHBG for the TU group (-46%; 35.08 ± 2.08 to 18.85 ± 1.02 nmol/L) compared to a significantly smaller decrease (-9%; 34.45± 2.70 to 31.32 ± 2.72 nmol/L) in the T-Gel group. The difference in SHBG response contributed to a significantly higher increase in free T concentrations from baseline to d365 in the oral TU group [3.07 ± 1.84 to 12.42 ± 5.08 ng/dL] versus T-Gel [3.20 ± 1.81 to 7.62 ± 3.92 ng/dL].
Conclusion: In addition to normalized total T levels, like T-Gel, oral TU also significantly reduced SHBG and increased free T – both being of higher magnitude than seen with T-Gel.
Ronald Swerdloff, Christina Wang, Marc Gittelman, Jed Kaminetsky, John K. Amory, Jay Newmark, Robert Dudley, Lundquist Institute at Harbor-UCLA, Torrance, CA; UroMedix and South Florida Medical Research, Aventura, FL; New York University School of Medicine, New York NY; University of Washington School of Medicine, Seattle, WA; Clarus Therapeutics, Northbrook, IL
Objective: A novel oral testosterone undecanoate formulation (TU, JATENZO) is now available for testosterone (T) replacement therapy (TRT) in appropriate men. The purpose of this analysis was to compare the effects of oral TU to those of a transdermal TRT (T-Gel, AndroGel 1%) on circulating total T, measured free T, and sex-hormone-binding globulin (SHBG) concentrations.
Methods: Hypogonadal men, aged 18-75 y/o, were enrolled in a one-year, open-label, multicenter, dose-titration trial. Subjects were randomized 1:1 between 2 treatment groups: oral TU or T-Gel. Total and free T concentrations were assayed at pre-designated time points. Standard safety measures, including prostate and cardiovascular biomarkers, have been previously described (Swerdloff and Dudley, Ther Adv Urol 2020;12:1-16).
Results: After one year of treatment, total and free T significantly increased in both groups. Total T concentrations went from 209.9 ± 8.52 ng/dL to 524.0 ± 19.1 ng/dL (BL to d365, mean ± SEM) and 218.9 ± 8.20 ng/dL to 424.7 ± 15.51 ng/dL, for the TU and T-Gel groups, respectively. There was a marked decrease in SHBG for the TU group (-46%; 35.08 ± 2.08 to 18.85 ± 1.02 nmol/L) compared to a significantly smaller decrease (-9%; 34.45± 2.70 to 31.32 ± 2.72 nmol/L) in the T-Gel group. The difference in SHBG response contributed to a significantly higher increase in free T concentrations from baseline to d365 in the oral TU group [3.07 ± 1.84 to 12.42 ± 5.08 ng/dL] versus T-Gel [3.20 ± 1.81 to 7.62 ± 3.92 ng/dL].
Conclusion: In addition to normalized total T levels, like T-Gel, oral TU also significantly reduced SHBG and increased free T – both being of higher magnitude than seen with T-Gel.
