Testosterone Therapy: Indications, Dosing, and Monitoring Guidelines

Indications and Expected Benefits

Therapy is indicated only for adult men with age‑related low testosterone who have sexual dysfunction and desire improvement in sexual function (Annals of Internal Medicine, 2020) 1.
The American College of Physicians advises against prescribing testosterone for low energy, reduced vitality, impaired physical function, or cognitive decline (Annals of Internal Medicine, 2020) 1.
Sexual function improves modestly with testosterone (effect size ≈ 0.35–0.45), whereas benefits for other symptoms are minimal (Annals of Internal Medicine, 2020) 2.

Nine reviewed trials used dose titration to reach target testosterone levels rather than fixed dosing, a strategy shown to be clinically superior (Annals of Internal Medicine, 2020) 2.
For intramuscular testosterone enanthate, dose adjustments should be guided by serum testosterone measured midway between injections (Annals of Internal Medicine, 2020) 2.
For transdermal gel, dose adjustments should be based on a morning serum testosterone level obtained before the next application (Annals of Internal Medicine, 2020) 2.

Serum testosterone should be measured 3–6 months after therapy initiation and dose adjusted if levels fall outside the mid‑normal range (≈ 400–700 ng/dL) (Annals of Internal Medicine, 2020) 2.
Symptoms must be reassessed at 12 months; therapy should be discontinued if there is no improvement in sexual function (Annals of Internal Medicine, 2020) 1.

Most efficacy data derive from trials lasting < 1 year, leaving long‑term benefits uncertain (Annals of Internal Medicine, 2020) 3.

The American College of Physicians (2020) recommends prescribing testosterone therapy only for men with age‑related low testosterone who have sexual dysfunction, and not for indications such as low energy, reduced vitality, impaired physical function, or cognitive decline. 4
The American College of Physicians (2020) advises using intramuscular testosterone formulations rather than transdermal preparations because they provide comparable efficacy at a lower cost. 4

The American Urological Association (2018) defines testosterone deficiency as a total testosterone level < 300 ng/dL on two separate early‑morning measurements together with relevant clinical symptoms. 5
The American Urological Association (2018) reports that up to 25 % of men receiving testosterone therapy do not meet these diagnostic criteria, and nearly half are not monitored appropriately during treatment. 5

Evidence is insufficient to determine the long‑term cardiovascular risk associated with testosterone or clomiphene therapy in men. 6
Data are lacking to assess whether long‑term use of testosterone or clomiphene increases the incidence of prostate cancer in men. 7

PSA should be measured according to established protocols, with referral for urology evaluation if PSA exceeds 4.0 ng/mL or rises by more than 1.0 ng/mL within the first 6 months of therapy, or by more than 0.4 ng/mL per year thereafter. 8