From the Guidelines
Testosterone replacement therapy is typically considered when a man has both clinical symptoms of low testosterone and consistently low total testosterone levels below 300 ng/dL (10.4 nmol/L). However, this is not a strict cutoff, as some men may experience symptoms at higher levels, particularly if their free testosterone is low. Before initiating therapy, at least two morning testosterone measurements should be taken, as levels fluctuate throughout the day and are highest in the morning. The decision to start treatment should be individualized based on symptoms, laboratory values, and a thorough discussion of potential benefits and risks, as recommended by the American College of Physicians 1.
Key Considerations
- The American Urological Association recommends a threshold of 300 ng/dL (10.4 nmol/L) to categorize a man as hypogonadal 1.
- Some men may experience symptoms at higher levels, particularly if their free testosterone is low 1.
- Treatment aims to restore testosterone levels to the mid-normal range (500-600 ng/dL) while alleviating symptoms 1.
- Regular monitoring of testosterone levels, hematocrit, PSA, and liver function is essential during therapy to ensure safety and efficacy 1.
Administration and Monitoring
- Testosterone therapy can be administered through various methods including injections (such as testosterone cypionate or enanthate), transdermal gels or patches, buccal tablets, or subcutaneous pellets 1.
- The choice of administration method should be individualized based on patient preferences and medical history.
- Regular monitoring of testosterone levels, hematocrit, PSA, and liver function is essential during therapy to ensure safety and efficacy 1.
From the FDA Drug Label
Prior to initiating testosterone gel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range
The FDA drug label does not specify the exact total testosterone level at which it is appropriate to begin testosterone replacement therapy, only that serum testosterone concentrations should be below the normal range.
From the Research
Total Testosterone Level for Testosterone Replacement Therapy
The total testosterone level at which it is appropriate to begin testosterone replacement therapy (TRT) is a topic of discussion in the medical community.
- According to the 2018 American Urological Association guidelines, a threshold of 300 ng/dL is recommended for prescribing TRT 2.
- A study published in 2008 suggests that TRT should be considered for symptomatic patients with a serum total testosterone level < 300 ng/dL 3.
- However, another study from 2019 found that human chorionic gonadotropin (hCG) monotherapy can be effective in treating hypogonadal symptoms in men with total testosterone levels > 300 ng/dL, with a mean testosterone improvement of 49.9% from a baseline of 362 ng/dL to 519.8 ng/dL 2.
- It's worth noting that the decision to start TRT should be based on individual patient symptoms and medical history, rather than solely on testosterone levels 4, 5.
- The Endocrine Society recommends that TRT be considered for men with symptomatic hypogonadism and a total testosterone level < 300 ng/dL, but also notes that some men may benefit from TRT at higher testosterone levels if they have persistent symptoms 6, 3.