Pharmacokinetics and Acceptability of Subcutaneous Injection of Testosterone Undecanoate

Journal of the Endocrine Society
Leo TurnerDavid J Handelsman

Abstract

Can injectable testosterone undecanoate (TU) be administered effectively and acceptably by the subcutaneous (SC) route? To investigate the acceptability and pharmacokinetics (PK) of SC injection of TU. Randomized sequence, crossover clinical study of SC vs IM TU injections. Ambulatory clinic of an academic andrology center. Twenty men (11 hypogonadal, 9 transgender men) who were long-term users of TU. injections. Intervention: Injection of 1000 mg TU (in 4 mL castor oil vehicle) by SC or IM route. Main Outcome Measures: Patient-reported pain, acceptability, and preference scales. PK by measurement of serum testosterone, dihydrotestosterone (DHT), and estradiol (E2) concentrations with application of population PK methods and dried blood spot (DBS) sampling. Pain was greater after SC compared with IM injection 24 hours (but not immediately) after injection but both routes were equally acceptable. Ultimately 11 preferred IM, 6 preferred SC, and 3 had no preference. The DBS-based PK analysis of serum testosterone revealed a later time of peak testosterone concentration after SC vs IM injection (8.0 vs 3.3 days) but no significant route differences in model-predicted peak testosterone concentration (8.4 vs 9.6 ng/mL) or mean reside...Continue Reading

References

Feb 2, 2010·Asian Journal of Andrology·Gideon SartoriusDavid J Handelsman
Nov 7, 2012·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·Michael SatorGerhard Garhöfer
May 16, 2013·European Journal of Endocrinology·Stefanie HahnerBruno Allolio
Nov 26, 2013·Contraception·James D Shelton, Vera Halpern
Feb 1, 2015·European Journal of Endocrinology·T MiddletonD J Handelsman
Aug 1, 2012·Clinical Pharmacokinetics·Tony K L KiangMary H H Ensom
Jan 26, 2018·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·David M WilsonMary H H Ensom
Mar 28, 2018·The Journal of Clinical Endocrinology and Metabolism·Sasha SavkovicDavid J Handelsman

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Citations

May 26, 2020·American Journal of Men's Health·Rodolfo A Rey, Romina P Grinspon
Mar 18, 2021·Bioanalysis·Yuling YuanJianghai Lu
Oct 27, 2021·The Journal of Clinical Endocrinology and Metabolism·Maria Gabriela FigueiredoShehzad Basaria

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