From the Guidelines
Testosterone replacement therapy (TRT) is recommended for managing a patient with hypogonadism and a testosterone level of 7.6 nmol/L, as it can help improve sexual function, increase energy, and enhance overall quality of life. The decision to initiate TRT should be based on a comprehensive medical evaluation, including assessment of symptoms, medical history, and comorbidities 1.
Key Considerations for TRT
- Baseline assessments should include prostate-specific antigen (PSA), hematocrit, and lipid profile before starting treatment.
- Monitoring should occur at 3,6, and 12 months after initiation, then annually, checking testosterone levels, hematocrit, PSA, and symptom improvement.
- Target testosterone levels should be in the mid-normal range (14-24 nmol/L) 1.
- TRT is contraindicated in patients with breast or prostate cancer, severe lower urinary tract symptoms, hematocrit >54%, or unstable cardiovascular disease.
Available Formulations for TRT
- Injectable testosterone cypionate or enanthate can be started at 100-200 mg intramuscularly every 1-2 weeks.
- Topical options include testosterone gel (50-100 mg applied daily to shoulders, upper arms, or abdomen) or transdermal patches (2-6 mg applied nightly).
- Testosterone pellets (implanted subcutaneously every 3-6 months) or buccal tablets (30 mg applied to the gum twice daily) are other options.
Lifestyle Modifications
- Weight loss, regular exercise, and adequate sleep should complement medical therapy to enhance the effectiveness of TRT and overall well-being 1.
It is essential to weigh the benefits and risks of TRT and consider individual patient factors, such as age, medical history, and comorbidities, when making treatment decisions 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 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. Dose adjustment: testosterone gel 1.62% can be dose adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment.
To manage a patient with hypogonadism and a testosterone level of 7.6 nmol/L, the following steps can be taken:
- Confirm the diagnosis: Ensure that serum testosterone concentrations have been measured in the morning on at least two separate days and are below the normal range.
- Initiate treatment: Start with a dose of 40.5 mg of testosterone gel 1.62% applied topically once daily in the morning to the shoulders and upper arms.
- Monitor and adjust: Titrate 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.
- Dose adjustment criteria:
- Decrease daily dose by 20.25 mg if pre-dose morning total serum testosterone concentration is greater than 750 ng/dL.
- No change if pre-dose morning total serum testosterone concentration is equal to or greater than 350 and equal to or less than 750 ng/dL.
- Increase daily dose by 20.25 mg if pre-dose morning total serum testosterone concentration is less than 350 ng/dL. 2
From the Research
Managing Testosterone Levels
To manage a patient with hypogonadism and a testosterone level of 7.6 nmol/L, the following steps can be taken:
- Diagnose hypogonadism only in men with symptoms and signs consistent with testosterone deficiency and unequivocally and consistently low serum testosterone concentrations 3
- Measure fasting morning total testosterone concentrations using an accurate and reliable assay as the initial diagnostic test 3
- Confirm the diagnosis by repeating the measurement of morning fasting total testosterone concentrations 3
Testosterone Replacement Therapy
Testosterone replacement therapy (TRT) can be used to manage hypogonadism:
- All approved testosterone replacement methods can restore normal serum testosterone concentrations and relieve symptoms in most hypogonadal men 4
- Selection of the method depends on the patient's preference with advice from the physician 4
- TRT can improve symptoms, signs, and well-being of hypogonadal men by restoring serum testosterone concentrations to physiologic levels 5
- Testosterone therapy should be initiated only after two morning total serum testosterone measurements show decreased levels, and all patients should be counseled on the potential risks and benefits before starting therapy 6
Monitoring and Adjusting Treatment
- Patients receiving testosterone therapy should be monitored to ensure testosterone levels rise appropriately, clinical improvement occurs, and no complications develop 6
- Clinicians should monitor men receiving testosterone therapy using a standardized plan that includes evaluating symptoms, adverse effects, and compliance; measuring serum testosterone and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating testosterone therapy 3
- Dose adjustment is possible with most delivery methods but may not be necessary in all hypogonadal men 4
Potential Risks and Benefits
- Potential benefits of testosterone therapy include increased libido, improved sexual function, improved mood and well-being, and increased muscle mass and bone density 6
- Potential risks include rising prostate-specific antigen levels, worsening lower urinary tract symptoms, polycythemia, and increased risk of venous thromboembolism 6
- The U.S. Food and Drug Administration warns that testosterone therapy may increase the risk of cardiovascular complications 6