What adjustments should be made to the dosage of Androgel (testosterone) in a 60-year-old male patient with normal total testosterone but elevated free testosterone, bioavailable testosterone, and free androgen levels?

From the Guidelines

No adjustments should be made to the dosage of Androgel (testosterone) in a 60-year-old male patient with normal total testosterone but elevated free testosterone, bioavailable testosterone, and free androgen levels, as the current evidence does not support dosage adjustments based on these specific parameters.

Key Considerations

• The American College of Physicians guidelines do not provide specific recommendations for dosage adjustments based on free testosterone, bioavailable testosterone, and free androgen levels 1.
• The primary concern in testosterone replacement therapy is to achieve and maintain normal total testosterone levels, rather than targeting specific levels of free or bioavailable testosterone 1.
• Monitoring of testosterone replacement therapy should focus on assessing symptomatic response, voiding symptoms, and sleep apnea, as well as regular blood tests to measure serum testosterone and PSA levels, and hematocrit or hemoglobin levels 1.
• There is no universal agreement on target levels for replacement therapy, but many clinicians aim for the mid- to upper-normal range to optimize response to treatment 1.

Dosage Adjustment Criteria

• Dosage adjustments should be based on clinical response and total testosterone levels, rather than free or bioavailable testosterone levels 1.
• If the patient reports an adequate clinical response to testosterone supplementation, there is no need for dosage adjustment, even if levels are in the low-normal range 1.
• If the clinical response is suboptimal and testosterone levels are no higher than the low-normal range, the testosterone dosage should be increased 1.

The FDA Drug Labels for testosterone (TOP) do not address this question.

From the Research

Adjusting Androgel Dosage

To adjust the dosage of Androgel in a 60-year-old male patient with normal total testosterone but elevated free testosterone, bioavailable testosterone, and free androgen levels, consider the following:

• The patient's total testosterone levels are within the normal range, but the free and bioavailable testosterone levels are elevated 2.
• The Endocrine Society clinical practice guideline recommends aiming for testosterone levels in the mid-normal range during treatment with any of the approved formulations 3.
• A study on the efficacy of changing testosterone gel preparations found that changing from Androgel to Testim can improve clinical and biochemical responsiveness in hypogonadal men, but this may not be necessary in this case since the patient's total testosterone levels are normal 4.
• Monitoring of testosterone therapy is crucial, and a standardized plan should be used to assess the patient's response to treatment 3.
• The free hormone theory suggests that measuring free testosterone may be more appropriate than measuring total serum testosterone, but the measurement of free testosterone is challenging and not always accurate 2.

Considerations for Dosage Adjustment

When considering adjusting the dosage of Androgel, take into account the following:

• The patient's symptoms and response to treatment should be monitored regularly 3.
• The dosage of Androgel may need to be adjusted to maintain testosterone levels in the mid-normal range 3.
• The patient's free and bioavailable testosterone levels should be monitored to ensure they are not excessively elevated 2.
• The potential risks and benefits of adjusting the dosage of Androgel should be carefully considered, including the risk of erythrocytosis and prostatic disease 5.