The HEAT-Registry (HEmatopoietic Affection by Testosterone): comparison of a transdermal gel vs long-acting intramuscular testosterone undecanoate in hypogonadal men

References

• Corona G, Goulis DG, Huhtaniemi I, et al. 2European academy of andrology (EAA) guidelines on investigation, treatment and monitoring of functional hypogonadism in males: endorsing organization: European society of endocrinology. Andrology. 2020;8(5):970–987.
   PubMed Web of Science ®Google Scholar
• Snyder PJ, Bhasin S, Cunningham GR, et al. Lessons from the testosterone trials. Endocr Rev. 2018;39(3):369–386.
   PubMed Web of Science ®Google Scholar
• Roy CN, Snyder PJ, Stephens-Shields AJ, et al. Association of testosterone levels with anemia in older men: a controlled clinical trial. JAMA Intern Med. 2017;177(4):480–490.
   PubMed Web of Science ®Google Scholar
• Rhoden EL, Morgentaler A. Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med. 2004;350(5):482–492.
   PubMed Web of Science ®Google Scholar
• Kenny AM, Prestwood KM, Gruman CA, et al. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. J Gerontol A Biol Sci Med Sci. 2001;56(5):M266–72.
   PubMed Web of Science ®Google Scholar
• Snyder PJ, Peachey H, Hannoush P, et al. Effect of testosterone treatment on bone mineral density in men over 65 years of age. J Clin Endocrinol Metab. 1999;84(6):1966–1972.
   PubMed Web of Science ®Google Scholar
• Sih R, Morley JE, Kaiser FE, et al. Testosterone replacement in older hypogonadal men: a 12-month randomized controlled trial. J Clin Endocrinol Metab. 1997;82(6):1661–1667.
   PubMed Web of Science ®Google Scholar
• Kapoor D, Goodwin E, Channer KS, et al. Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes. Eur J Endocrinol. 2006;154(6):899–906.
   PubMed Web of Science ®Google Scholar
• Calof OM, Singh AB, Lee ML, et al. Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials. J Gerontol A Biol Sci Med Sci. 2005;60(11):1451–1457.
   PubMed Web of Science ®Google Scholar
• Aghazadeh M, Pastuszak AW, Johnson WG, et al. Elevated dihydrotestosterone is associated with testosterone induced erythrocytosis. J Urol. 2015;194(1):160–165.
   PubMed Web of Science ®Google Scholar
• Fernandez-Balsells MM, Murad MH, Lane M, et al. Clinical review 1: adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2010;95(6):2560–2575.
   PubMed Web of Science ®Google Scholar
• Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med. 2010;363(2):109–122.
   PubMed Web of Science ®Google Scholar
• Zitzmann M, Nieschlag E. Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular testosterone undecanoate therapy in hypogonadal men. J Clin Endocrinol Metab. 2007;92(10):3844–3853.
   PubMed Web of Science ®Google Scholar
• Pastuszak AW, Gomez LP, Scovell JM, et al. Comparison of the effects of testosterone gels, injections, and pellets on serum hormones, erythrocytosis, lipids, and prostate-specific antigen. Sex Med. 2015;3(3):165–173.
   PubMed Web of Science ®Google Scholar
• Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. Lancet Diabetes Endocrinol. 2021;9(1):32–45.
   PubMed Web of Science ®Google Scholar
• Ohlander SJ, Varghese B, Pastuszak AW. Erythrocytosis following testosterone therapy. Sex Med Rev. 2018;6(1):77–85.
   PubMed Web of Science ®Google Scholar
• Bachman E, Feng R, Travison T, et al. Testosterone suppresses hepcidin in men: a potential mechanism for testosterone-induced erythrocytosis. J Clin Endocrinol Metab. 2010;95(10):4743–4747.
   PubMed Web of Science ®Google Scholar
• Hennigar SR, Berryman CE, Harris MN, et al. Testosterone administration during energy deficit suppresses hepcidin and increases iron availability for erythropoiesis. J Clin Endocrinol Metab. 2020;105(4):dgz316.
   PubMed Web of Science ®Google Scholar
• Guo W, Schmidt PJ, Fleming MD, et al. Hepcidin is not essential for mediating testosterone's effects on erythropoiesis. Andrology. 2020;8(1):82–90.
   PubMed Web of Science ®Google Scholar
• Bhattacharya RK, Khera M, Blick G, et al. Effect of 12 months of testosterone replacement therapy on metabolic syndrome components in hypogonadal men: data from the Testim registry in the US (TRiUS). BMC Endocr Disord. 2011;11(1):18.
   PubMedGoogle Scholar
• Rosen RC, Wu FC, Behre HM, et al. Registry of hypogonadism in men (RHYME): design of a multi-national longitudinal, observational registry of exogenous testosterone use in hypogonadal men. Aging Male. 2013;16(1):1–7.
   PubMed Web of Science ®Google Scholar
• https://uroweb.org/guideline/male-hypogonadism/.
   Google Scholar
• Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab. 1999;84(10):3666–3672.
   PubMed Web of Science ®Google Scholar
• Zitzmann M, Depenbusch M, Gromoll J, et al. Prostate volume and growth in testosterone-substituted hypogonadal men are dependent on the CAG repeat polymorphism of the androgen receptor gene: a longitudinal pharmacogenetic study. J Clin Endocrinol Metab. 2003;88(5):2049–2054.
   PubMed Web of Science ®Google Scholar
• Lowe GD. Rheological influences on thrombosis. Baillieres Best Pract Res Clin Haematol. 1999;12(3):435–449.
   PubMed Web of Science ®Google Scholar
• Lowe GD, Forbes CD. Platelet aggregation, haematocrit, and fibrinogen. Lancet. 1985;325(8425):395–396.
   Google Scholar
• Wannamethee G, Perry IJ, Shaper AG. Haematocrit, hypertension and risk of stroke. J Intern Med. 1994;235(2):163–168.
   PubMed Web of Science ®Google Scholar
• Sansone A, Sansone M, Selleri R, et al. Monitoring testosterone replacement therapy with transdermal gel: when and how? J Endocrinol Invest. 2019;42(12):1491–1496.
   PubMed Web of Science ®Google Scholar
• Zitzmann M, Junker R, Kamischke A, et al. Contraceptive steroids influence the hemostatic activation state in healthy men. J Androl. 2002;23:503–511.
   PubMedGoogle Scholar
• Bhasin S, Woodhouse L, Casaburi R, et al. Older men are as responsive as young men to the anabolic effects of graded doses of testosterone on the skeletal muscle. J Clin Endocrinol Metab. 2005;90(2):678–688.
   PubMed Web of Science ®Google Scholar
• Dobs AS, Meikle AW, Arver S, et al. Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men. J Clin Endocrinol Metab. 1999;84(10):3469–3478.
   PubMed Web of Science ®Google Scholar
• Kaufman JM, Miller MG, Garwin JL, et al. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011;8(7):2079–2089.
   PubMed Web of Science ®Google Scholar
• Eckardstein S, Nieschlag E. Treatment of male hypogonadism with testosterone undecanoate injected at extended intervals of 12 weeks: a phase II study. J Androl. 2002;23(3):419–425.
   PubMedGoogle Scholar
• Weinbauer GF, Partsch C-J, Zitzmann M, et al. Pharmacokinetics and degree of aromatization rather than total dose of different preparations determine the effects of testosterone: a nonhuman primate study in Macaca fascicularis. J Androl. 2003;24(5):765–774.
   PubMedGoogle Scholar
• Abildgaard J, Petersen JH, Bang AK, et al. Long-term testosterone undecanoate treatment in the elderly testosterone deficient male: an observational cohort study. Andrology. 2022;10(2):322–332.
   PubMed Web of Science ®Google Scholar
• Strange RC, König CS, Adeeba A, et al. Testosterone therapy: Increase in hematocrit is associated with decreased mortality. Androgens. 2021;2(1):150–159.
   Google Scholar
• König CS, Balabani S, Hackett GI, et al. Testosterone therapy: an assessment of the clinical consequences of changes in hematocrit and blood flow characteristics. Sex Med Rev. 2019;7(4):650–660.
   PubMed Web of Science ®Google Scholar