This website has been developed by Besins Healthcare (UK) Ltd.

This website has separate sections for healthcare professionals (containing promotional information), and patients who have been prescribed Testogel® (testosterone) within the UK.

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This website is provided for HCPs in the UK by Besins Healthcare (UK) Ltd.

Testosterone therapy
(TTh)

Safety of TTh

Based on existing evidence, it appears as though patients with a correct diagnosis of hypogonadism and normalisation of circulating testosterone from administration of testosterone therapy (TTh) have reduced cardiovascular (CV) events and CV death (MACE).1

The weight of current medical evidence from well performed studies supports that testosterone when replaced to adequate levels (in the normal healthy range) has no overall adverse effects on the cardiovascular system and has shown benefits in patients not suffering from existing severe cardiac, hepatic or renal insufficiency, or ischaemic disease.1

Please also refer to warnings and precautions for use in those with existing CV disease.

TTh can impact male fertility by lowering sperm count. UK guidelines indicate that TTh should be contraindicated in men with an active desire to have children.2

TTh commonly interrupts or reduces spermatogenesis due to negative feedback on the hypothalamic-pituitary-testicular (HPT) axis.3,4

Guidelines from the European Association of Urology (EAU), the British Society for Sexual Medicine (BSSM), the International Consultation of Sexual Medicine (ICSM), the International Society of Sexual Medicine (ISSM), the Endocrine Society (ES), and the International Study of the Ageing Male (ISSAM) conclude that there is no compelling evidence that TTh is associated with an increased risk of prostate cancer.2

Please note that Testogel® is contraindicated in cases of known or suspected prostate cancer.

Please consult SmPC for full list of warnings and precautions.

TTh may increase haematocrit levels. UK guidelines indicated that TTh should be contraindicated if haematocrit is >0.54.2

Haematocrit should be monitored before treatment, at 3-6 months, 12 months and annually thereafter. A decrease in TTh dosage or switching preparation may be required if haematocrit is >0.54. If haemocrit remains high, consider stopping TTh and reintroducing at a lower dose.8

References

  1. Corona G, Sforza A, Maggi M. Testosterone Replacement Therapy: Long-Term Safety and Efficacy. World J Mens Health. 2017;35(2):65–76.
  2. Hackett G, Kirby M, Edwards D, et al. British Society for Sexual Medicine Guidelines on Adult Testosterone Deficiency, With Statements for UK Practice. J Sex Med. 2017;14(12):1504–1523.
  3. Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med. 2010;363(2):109–122.
  4. Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PloS One. 2014;9(1):e85805.

TES/2022/045. February 2023.

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: pharmacovigilance@besins-healthcare.com

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