What is the protocol for monitoring a patient taking testosterone (hypogonadism treatment) gel?

From the Guidelines

Monitoring a patient taking testosterone gel for hypogonadism treatment involves regular blood tests to check testosterone levels, typically every 3-6 months initially and then annually once stable, as recommended by the most recent and highest quality study 1.

Key Components of Monitoring

• Blood tests should measure total testosterone, complete blood count, liver function, lipid profile, and PSA (prostate-specific antigen) in men over 40.
• Blood samples should be drawn in the morning, 2-4 hours after gel application for accurate readings.
• Physical examinations are also important to assess for side effects like acne, hair growth patterns, mood changes, and signs of cardiovascular issues.
• The target testosterone level is typically 400-700 ng/dL for most patients.

Importance of Monitoring

Monitoring is crucial because testosterone therapy can affect red blood cell production (potentially causing polycythemia), liver function, cholesterol levels, and prostate health.

• Patients should also self-monitor for symptoms like chest pain, shortness of breath, or swelling in the legs which could indicate complications.
• Adjustments to dosage may be needed based on both laboratory results and symptom response, as individual absorption of testosterone gel can vary significantly, as noted in 1 and 1.

Considerations for Testosterone Therapy

Testosterone therapy may provide small improvements in sexual functioning and quality of life but little to no benefit for other common symptoms of aging, according to 1.

• Long-term efficacy and safety of testosterone therapy are unknown, highlighting the need for ongoing monitoring and evaluation.

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 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. Additionally, serum testosterone concentration should be assessed periodically thereafter. Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically.

The protocol for monitoring a patient taking testosterone gel for hypogonadism treatment includes:

• Confirming the diagnosis of hypogonadism by measuring serum testosterone levels on at least two separate days
• Titration of dose based on pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment
• Periodic assessment of serum testosterone concentration
• Monitoring for BPH: assessing patients with benign prostatic hyperplasia (BPH) for worsening signs and symptoms
• Laboratory monitoring: periodically assessing serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations 2 2 2

From the Research

Monitoring Protocol

The protocol for monitoring a patient taking testosterone gel for hypogonadism treatment involves regular check-ups to assess the effectiveness of the treatment and potential side effects.

• Mammograms and monitoring of prostate-specific antigen (PSA), hematocrit, and lipid levels are recommended for patients taking testosterone 3.
• Monitoring for prostate disease through PSA measurements and digital rectal examination is recommended for hypogonadal men in the older age groups when treated with testosterone 4.
• Assessment of testosterone replacement therapy (TRT) with transdermal gels at its peak and at its minimum could be useful in providing a finely tailored treatment for hypogonadal men, both preventing supra-physiological levels and maintaining adequate concentrations through the day 5.
• Monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with testosterone treatment of hypogonadal men 6.

Laboratory Tests

Regular laboratory tests are necessary to monitor the patient's response to testosterone gel treatment.

• Serum total testosterone, free testosterone, and bioavailable testosterone levels should be measured to assess the effectiveness of the treatment 5.
• Hematocrit and hemoglobin levels should be monitored to assess the risk of erythrocytosis 6.
• Lipid levels should be monitored to assess the risk of cardiovascular disease 3.
• PSA levels should be monitored to assess the risk of prostate cancer 4, 6.

Clinical Evaluation

Regular clinical evaluations are necessary to monitor the patient's overall health and response to testosterone gel treatment.

• Patients should be evaluated for signs and symptoms of prostate disease, such as elevated PSA levels or abnormal digital rectal examination findings 4, 6.
• Patients should be evaluated for signs and symptoms of erythrocytosis, such as increased hematocrit or hemoglobin levels 6.
• Patients should be evaluated for changes in lipid levels, such as increased low-density lipoprotein (LDL) cholesterol or decreased high-density lipoprotein (HDL) cholesterol 3.
• Patients should be evaluated for changes in bone mineral density, such as increased bone density in the spine or hip 4, 6.