Injectable testosterone undecanoate for the treatment of hypogonadism

Introduction: Injectable testosterone undecanoate (TU) is a long-acting testosterone (T) formulation available for the treatment of male hypogonadism (HG) since 2003.

Areas covered: The efficacy and safety of injectable TU are assessed, as obtained by meta-analyzing available evidence. An extensive Medline, Embase and Cochrane search was performed. All uncontrolled and placebo-controlled randomized clinical trials (RCTs), evaluating the effect of injectable TU on different outcomes, were included. Of the 98 retrieved articles, 33 were included in the study. Among those, 11 were placebo-controlled RCTs. Injectable TU was significantly associated with a reduction of fat mass and HbA1c in both controlled and uncontrolled trials, in particular when hypogonadal subjects were enrolled. Similar results were observed for the improvement of erectile function. In addition, TU ameliorated several other outcomes, including blood pressure, lipid profile, waist circumference and body mass index in uncontrolled studies, but these data were not confirmed in placebo-controlled trials. The treatment was well tolerated and no risk of prostate cancer or cardiovascular disease was observed.

Expert opinion: Injectable TU is a safe and effective treatment for male HG. The possibility of a therapeutic intervention just four to five times per year frees the patient, at least partially, from having a chronic condition, thus maintaining a positive, active role in self-caring.

Keywords: erectile dysfunction; obesity; testosterone undecanoate; weight loss.

Similar articles

Yassin DJ, Doros G, Hammerer PG, Yassin AA. Yassin DJ, et al. J Sex Med. 2014 Jun;11(6):1567-76. doi: 10.1111/jsm.12523. Epub 2014 Apr 8. J Sex Med. 2014. PMID: 24712761

Moon DG, Park MG, Lee SW, Park K, Park JK, Kim SW, Park NC, Ahn TY, Paick JS, Seo JT, Yang DY, Lee JY, Kim JJ. Moon DG, et al. J Sex Med. 2010 Jun;7(6):2253-2260. doi: 10.1111/j.1743-6109.2010.01765.x. Epub 2010 Mar 15. J Sex Med. 2010. PMID: 20345732 Clinical Trial.

Hackett G, Cole N, Saghir A, Jones P, Strange RC, Ramachandran S. Hackett G, et al. BJU Int. 2016 Nov;118(5):804-813. doi: 10.1111/bju.13516. Epub 2016 May 27. BJU Int. 2016. PMID: 27124889 Clinical Trial.

Edelstein D, Basaria S. Edelstein D, et al. Expert Opin Pharmacother. 2010 Aug;11(12):2095-106. doi: 10.1517/14656566.2010.505920. Expert Opin Pharmacother. 2010. PMID: 20642374 Review.

Corona G, Rastrelli G, Morgentaler A, Sforza A, Mannucci E, Maggi M. Corona G, et al. Eur Urol. 2017 Dec;72(6):1000-1011. doi: 10.1016/j.eururo.2017.03.032. Epub 2017 Apr 20. Eur Urol. 2017. PMID: 28434676 Review.

Cited by

Azevedo RA, Gualano B, Teixeira TA, Nascimento BCG, Hallak J. Azevedo RA, et al. Front Toxicol. 2024 Apr 22;6:1379272. doi: 10.3389/ftox.2024.1379272. eCollection 2024. Front Toxicol. 2024. PMID: 38711907 Free PMC article. Review.

Kim DW, Song SH. Kim DW, et al. Korean J Intern Med. 2023 May;38(3):303-321. doi: 10.3904/kjim.2022.338. Epub 2023 Apr 20. Korean J Intern Med. 2023. PMID: 37077132 Free PMC article. Review.

Isidori AM, Aversa A, Calogero A, Ferlin A, Francavilla S, Lanfranco F, Pivonello R, Rochira V, Corona G, Maggi M. Isidori AM, et al. J Endocrinol Invest. 2022 Dec;45(12):2385-2403. doi: 10.1007/s40618-022-01859-7. Epub 2022 Aug 26. J Endocrinol Invest. 2022. PMID: 36018454 Free PMC article.

Romejko K, Rymarz A, Sadownik H, Niemczyk S. Romejko K, et al. Nutrients. 2022 Aug 21;14(16):3438. doi: 10.3390/nu14163438. Nutrients. 2022. PMID: 36014945 Free PMC article. Review.

Madsen MC, Heijer MD, Pees C, Biermasz NR, Bakker LEH. Madsen MC, et al. Endocr Connect. 2022 Jul 25;11(8):e220112. doi: 10.1530/EC-22-0112. Print 2022 Aug 1. Endocr Connect. 2022. PMID: 35904217 Free PMC article. Review.