From the Guidelines
The management of a single testosterone result of 7.6mmol/l should involve a comprehensive evaluation, including a thorough medical history, physical examination, and laboratory tests, before considering testosterone replacement therapy (TRT), as recommended by the American College of Physicians 1.
Evaluation and Diagnosis
To confirm the diagnosis of hypogonadism, two total testosterone measurements should be taken on separate occasions, with both conducted in an early morning fashion, as suggested by the American Urological Association (AUA) guideline 1. The diagnosis of low testosterone should be made only when patients have low total testosterone levels combined with symptoms and/or signs.
Treatment Options
If hypogonadism is confirmed, testosterone replacement therapy (TRT) may be considered, with options including intramuscular testosterone cypionate or enanthate, daily transdermal gels, patches, or buccal tablets, as well as long-acting testosterone undecanoate injections 1.
Monitoring and Safety
Before initiating TRT, baseline assessments should include prostate-specific antigen (PSA), hematocrit, and lipid profile, with regular monitoring to avoid polycythemia and monitor prostate health, as recommended by the AUA guideline 1.
Lifestyle Modifications
Lifestyle modifications, including weight loss, regular exercise, and adequate sleep, should complement medical therapy, as suggested by the study on practical use of pharmacotherapy for obesity 1. Some key points to consider when managing a patient with confirmed hypogonadism and low testosterone levels include:
- TRT is contraindicated in men with breast or prostate cancer, untreated severe sleep apnea, severe lower urinary tract symptoms, or erythrocytosis, as stated in the AUA guideline 1
- The method of testosterone replacement should be individualized for each patient, with transdermal testosterone preparations suggested for most hypogonadal men, as recommended by the study on practical use of pharmacotherapy for obesity 1
- Testosterone levels should be tested 2 to 3 months after treatment initiation, and/or after any dose change, to determine that normal serum testosterone concentrations are being achieved, as suggested by the study on practical use of pharmacotherapy for obesity 1
From the FDA Drug Label
Prior to initiating testosterone gel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. The recommended starting dose of testosterone gel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning to the shoulders and upper arms. To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment.
For a patient with confirmed hypogonadism and a single testosterone result of 7.6 mmol/L, the management approach would be to:
- Confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days.
- Initiate treatment with testosterone gel 1.62% at the recommended starting dose of 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning to the shoulders and upper arms.
- Monitor and adjust the dose based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment.
- Assess serum testosterone concentration periodically thereafter to ensure proper dosing and adjust the dose as needed according to the dose adjustment criteria:
- Greater than 750 ng/dL: Decrease daily dose by 20.25 mg (1 pump actuation or the equivalent of one 20.25 mg packet)
- Equal to or greater than 350 and equal to or less than 750 ng/dL: No change: continue on current dose
- Less than 350 ng/dL: Increase daily dose by 20.25 mg (1 pump actuation or the equivalent of one 20.25 mg packet) 2 2 2
From the Research
Management Approach for Confirmed Hypogonadism
The management approach for a patient with confirmed hypogonadism and low testosterone levels, such as a single testosterone result of 7.6mmol/l, involves testosterone replacement therapy (TRT) to restore serum testosterone concentrations to physiologic levels 3, 4, 5, 6.
Testosterone Replacement Therapy (TRT) Options
TRT options include:
- Topical gels, such as testosterone 2% gel, which can be applied to the front and inner thighs 3, 6
- Oral formulations, such as JATENZO and TLANDO, which are approved by the US Food and Drug Administration 5
- Patches and short- and long-acting injectables 4, 5
Efficacy and Safety of TRT
Studies have shown that TRT can improve symptoms, signs, and well-being of hypogonadal men by restoring serum testosterone concentrations to physiologic levels 3, 4, 6.
- A study on testosterone 2% gel found that 77.5% of patients achieved serum total testosterone concentrations within the normal physiologic range 3
- Another study on testosterone gel 2% found that 76.1% of subjects met the average testosterone concentration criteria on Day 90 6
- TRT has been shown to be generally well-tolerated, with common adverse events being mild and moderate skin reactions 3, 6
Selection of TRT Method
The selection of the TRT method depends on the patient's preference with advice from the physician 4.