Androgen replacement has been indicated in patients with symptomatic hypogonadism having confirmed two low early morning testosterone and considering the underlying cause.

Oral replacement is not generally recommended due to very poor absorption. Standard therapy is IM injection of testosterone.

Monitoring

• Prostate-specific antigen (PSA): PSA should be measured at the start of therapy and annually thereafter. If PSA is increasing over time then a referral to urology and stopping testosterone supplementation should be considered.
• Full blood count: FBC should be performed and treatment reduced or stopped if polycythaemia or haematocrit is greater than 50%.

Androgens

Testosterone intramuscular injection (IM)

(Testosterone propionate/ testosterone phenylpropionate/ testosterone isocaproate/ testosterone decanoate)

• Sustanon 250 solution for injection 250mg in 1ml (£2.45 = 1ml amp)

Indications

• Male hypogonadism

Dose

• Usual therapy is 250mg IM injection every 3-4 weeks.
• For patients who report large swings in their symptomatic response, an alternative dosing schedule of a lower dose more frequently, may be given

Notes

1. Contains arachis oil and is contraindicated in patients allergic to peanuts or soya

The following second line treatment options cost considerably more and should be reserved for those patients with very fluctuant symptoms on Sustanon or those unable to attend frequent injection appointments. Transdermal preparations may be useful for patients with needle phobia.

Testosterone intramuscular injection (IM) (long-acting)

(Testosterone undecanoate)

• Nebido oily solution for injection 250mg in 1ml (£87.11 = 4ml vial)

Indications

• Male hypogonadism

Dose

• 1g every 10-14 weeks,to be given over 2 minutes by deep intramuscular injection. A second dose maybe given after 6 weeks to achieve rapid steady state plasma testosterone levelsand then every 10-14 weeks

Testosterone transdermal gel

• Testogel gel 16.2mg/g (£31.11 = 88g pump)
  • One pump actuation delivers 1.25g gel containing 20.25mg testosterone
• Testogel gel 40.5mg/2.5g (£31.11 = 30 x 2.5g sachets)
  • One 2.5g sachet contains 40.5mg testosterone
• Tostran gel 2% (£28.63 = 60g pump)
  • One pump actuation delivers 0.5g gel containing 10mg testosterone

Indications

• Male hypogonadism

Dose

• Testogel 16.2mg/g pump:
  • Apply 40.5mg (two actuations) once each morning. Increase dose in steps of 20.25mg (one actuation), according to response; max 81mg (4 actuations) per day
• Testogel 40.5mg/2.5g sachet:
  • Apply 40.5mg (1 x 2.5g sachet) once each morning. Increase dose in half sachet steps (1.25g of gel) according to response; max 81mg (2 x 2.5g sachet) per day
• Tostran 2% pump:
  • Apply 60mg (six actuations) once each morning. Adjust dose according to response; max 80mg (eight actuations) per day

Notes

1. Avoid skin contact with gel application sites to prevent testosterone transfer to other people, especially pregnant women and children—consult product literature and see note 4.
2. Refer to individual product literature for specific application directions
3. Do not apply to the genital areas
4. MHRA Drug Safety Update (January 2023): Topical testosterone: risk of harm to children following accidental exposure
   1. Inform patients that accidental transfer to other people can lead to increased blood testosterone levels in the other person.
   2. Advise patients of the possible effects should accidental exposure occur in adult women (facial and/or body hair growth, deepening of voice, changes in menstrual cycle) or children (genital enlargement and premature puberty, including development of pubic hair).
   3. Counsel patients on methods to reduce the risks of accidental exposure, including washing their hands with soap and water after application, covering the application site with clean clothing (such as a t-shirt) once the gel has dried, and washing the application area with soap and water before physical contact with another person.

Anti-androgens

Cyproterone acetate

• Tablets 50mg, 100mg (£111.14 = 300mg daily)

Notes

1. Hepatotoxicity: Direct hepatic toxicity including jaundice, hepatitis and hepatic failure has been reported (usually after several months) in patients treated with cyproterone acetate 200-300 mg daily. Liver function tests should be performed before treatment and whenever symptoms suggestive of hepatotoxicity occur-if confirmed cyproterone should normally be withdrawn. Cyproterone is no longer recommended for long term use
2. Prevention of tumour flare in patients starting treatment with gonadorelin analogues should be achieved by the use of cyproterone 300mg daily in 2 or 3 divided doses starting at least 3 days before the gonadorelin analogue and continuing for 3 weeks.
3. Megestrol acetate 160mg daily (see 8.3.2) or cyproterone acetate 50-150mg daily may be used in low doses to control unacceptable symptomatic flushes associated with LHRH analogues

5 alpha-reductase inhibitors

Finasteride

• Tablets 5mg (£1.77 = 28 tablets)

Indications

• Benign prostatic hyperplasia

Notes

1. Finasteride is an alternative to alpha blockers in older men, particularly if the prostate is larger than 40mL. There is evidence that finasteride reduces the risk of symptomatic progression due to prostatic enlargement. The urologists are happy to advise on management
2. Combination therapy with alpha blockers is appropriate for men with bothersome moderate to severe LUTS and prostates estimated greater than 30g or a PSA greater than 1.4ng/mL. An attempt to withdraw the alpha blocker may be made at 9-12 months and finasteride continued as monotherapy. If symptoms recur the alpha blocker can be restarted. One further attempt to withdraw the alpha blocker 6 months later would be appropriate
3. Relief of symptoms may take several months
4. Urologists use finasteride off-licence in patients who have prostatic bleeds
5. Patients should stop finasteride immediately if they develop depression and inform a healthcare professional