Diagnosing and managing testosterone deficiency in adult men1
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
- Consider the use of validated questionnaires, such as the Androgen Deficiency in the Ageing Male (ADAM) questionnaire or the Ageing Males’ Symptoms (AMS) Scale
Physical examination
- Measure height, weight, BMI and waist circumference6
- Assess the degree of body hair (including facial and pubic)6
- Arrange blood investigations, including prostate-specific antigen (PSA), haematocrit, and appropriate tests according to physical findings and to determine cardiovascular (CV) risk
Laboratory diagnosis
Serum testosterone- 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
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 |
|
|
|
| Testosterone undecanoate | Intramuscular injection | Every 10–14 weeks, adjusted to maintain trough testosterone >12 nmol/L |
|
|
| Testosterone enantate | Intramuscular injection | Every 2–3 weeks | Can be administered every 3–6 weeks for maintenance, according to individual requirement18 |
|
| 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 |
||
Recommendations
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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Licensed for: In the UK, Nebido® (testosterone undecanoate) is Licensed for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Nebido® (testosterone undecanoate) Prescribing Information
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Page last modified 14 Jul 2020
- PP-NEB-GB-0426 February 2021
