Diagnosing and managing testosterone deficiency in adult men1

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Adapted from Minhas and Mulhall, 2017.5

AI – aromatase inhibitor, CV – cardiovascular, CVD – cardiovascular disease, FSH – follicle-stimulating hormone, FT – free testosterone, HCG – human chorionic gonadotropin, LH – luteinising hormone, MRI – magnetic resonance imaging, PSA – prostate-specific antigen, SERM – selective oestrogen receptor modulator, SHBG – sex hormone-binding globulin, T Therapy – testosterone therapy, TT – total testosterone

*For men with TT levels <5.2 nmol/L plus low LH and FSH or increased prolactin levels, refer to endocrinology or arrange a pituitary MRI scan to exclude a pituitary adenoma.3,4

**These drugs should not be used if pituitary function is compromised. SERMs and AIs are not currently licensed for TD.

***Please refer to SmPC for the posology and method of administration of Nebido

 

Who should be screened for TD?

  • Adult men with consistent and multiple signs of TD
  • All men presenting with ED, loss of spontaneous erections or low sexual desire
  • All men with type 2 diabetes mellitus, BMI >30 kg/m2 or waist circumference >102 cm (40.2 inches)
  • All men on long-term opiate, antipsychotic or anticonvulsant medication

History taking

  • Enquire about previous and current prescription and non-prescription drug use5
  • Assess and exclude systemic illness, ongoing acute disease, malabsorption and malnutrition5
 

Physical examination

  • Measure height, weight, BMI and waist circumference6
  • Assess the degree of body hair (including facial and pubic)6
 
  • Examine for the presence and degree of breast enlargement, and abnormalities of the penis, testicles5,6 and scrotum6
  • Check the prostate via digital rectal examination (DRE)5

 

  • Arrange blood investigations, including prostate-specific antigen (PSA), haematocrit, and appropriate tests according to physical findings and to determine cardiovascular (CV) risk
 

Laboratory diagnosis

- measure between 7–11 am,5 with a reliable method, on at least 2 occasions5,7 preferably 4 weeks apart. Fasting levels should be obtained where possible, as recommended by the European Association of Urology (EAU).5

 

If low/borderline, measure LH* and FSH, **plus SHBG to calculate FT

- can be calculated using our Free testosterone calculator

FSH – follicle-stimulating hormone, LH – luteinising hormone, SHBG – sex hormone-binding globulin
*LH to differentiate primary from secondary TD. **FSH is only necessary if fertility is an issue.

Main contraindications to testosterone therapy7

  • Androgen-dependent carcinoma of the prostate or of the male mammary gland
  • An active desire to have children
  • The use of nebido is contraindicated in women
  • Haematocrit >54%
  • Severe chronic heart failure [New York Heart Association (NYHA) class IV]
 

Testosterone therapy and ED in hypogonadism

  • Testosterone therapy (T Therapy) is appropriate for treating ED,7,8 particularly at TT levels <8 nmol/L,7 and for salvaging ED treatment failures with oral medication, particularly at TT levels <10.4 nmol/L9
  • T Therapy may reduce the need for more invasive and expensive second- and third-line treatments10
  • A PDE5i can be prescribed for all men with ED when commencing T Therapy as long as there are no contraindications, because T Therapy can take many months to correct ED
PDE5i – phosphodiesterase type 5 inhibitor
Formulation Route of administration Frequency of administration Advantages Disadvantages
Testosterone 1%, 1.62%* and 2% gel available
*1.62% = 16.2 mg/g
Transdermal gel 1% (sachets/tubes) 1.62%* (pump) 2% (pump)
*1.62% = 16.2 mg/g
  • Applied daily16
  • May require dose titration
  • Fast onset
  • Provides uniform and normal serum levels for 24 hours7
  • Skin irritation at application site
  • Potential for interpersonal transfer
  • Compliance may be an issue long-term
Testosterone undecanoate Intramuscular injection Every 10–14 weeks, adjusted to maintain trough testosterone >12 nmol/L
  • Steady state levels
  • Reduced frequency of administration improves compliance
  • Possible injection site pain/reaction17
Testosterone enantate Intramuscular injection Every 2–3 weeks Can be administered every 3–6 weeks for maintenance, according to individual requirement18
  • Levels fluctuate
  • Possible injection site pain/reaction18
Mix of 4 testosterone esters (including propionate) as Sustanon 250 Intramuscular injection Usually administered every 3 weeks
May cause a reaction at the injection site19

References

  • Hackett G et al. The British Society for Sexual Medicine guidelines on adult testosterone deficiency with statements for UK practice. J Sex Med 2017;14:1504-23. Return to content
  • Minhas S & Mulhall J (Eds). Male sexual dysfunction. A clinical guide (2017). John Wiley and Sons Ltd, West Sussex, UK Return to content
  • Khera M et al. Diagnosis and Treatment of Testosterone Deficiency: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med 2016;13:1787-804. Return to content
  • Bhasin S et al. Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010;95:2536-59. Return to content
  • Dohle GH et al. Guidelines on Male Hypogonadism. European Association of Urology 2017. Available at: http://uroweb.org/guideline/male-hypogonadism/ (Accessed September 2020). Return to content
  • Lunenfeld B et al. Recommendations on the diagnosis, treatment and monitoring of hypogonadism in men. Ageing Male 2015;18:5-15. Return to content
  • Dean JD et al. The International Society for Sexual Medicine’s process of care for the assessment and management of testosterone deficiency in adult men. J Sex Med 2015;12:1660-86. Return to content
  • British Society of Sexual Medicine. Guidelines on the management of sexual problems in men: the role of androgens 2010. (Accessed September 2020). Return to content
  • Buvat J et al. Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study). J Sex Med 2011;8:284-93. Return to content
  • Lowe G et al. Non-invasive management of primary phosphodiesterase type 5 inhibitor failure in patients with erectile dysfunction. Ther Adv Urol 2009;1:235-42. Return to content
  • Dohle GH et al. EAU guidelines on male hypogonadism (Limited text update March 2017). Available at: http://uroweb.org/guideline/male-hypogonadism/?type=pocket-guidelines (Accessed September 2020). Return to content
  • Besins Healthcare (UK) Ltd. Testogel Summary of Product Characteristics. August 2018. Return to content
  • Bayer PLC. Nebido 1000mg/4mL, solution for injection Summary of Product Characteristics. March 2020. Return to content
  • Alliance Pharmaceuticals. Testosterone enantate ampoules Summary of Product Characteristics. April 2020. Return to content
  • Aspen Pharma Trading Limited. Sustanon 250 Summary of Product Characteristics. July 2020. Return to content

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