From the Guidelines
Testosterone replacement therapy is recommended for a total testosterone level of 254 ng/dL, which is below the normal adult male range (typically 300-1000 ng/dL). Treatment options include injectable testosterone cypionate (100-200 mg every 1-2 weeks), testosterone enanthate (100-200 mg every 1-2 weeks), topical gels (50-100 mg applied daily), transdermal patches (4-6 mg applied nightly), or testosterone pellets (implanted subcutaneously every 3-6 months). For most patients, starting with testosterone cypionate 100 mg weekly by intramuscular injection or a daily application of 5g testosterone gel (delivering 50 mg testosterone) is appropriate, as suggested by the American College of Physicians 1.
Some key points to consider:
- Treatment should be monitored with testosterone levels checked after 2-3 months, aiming for mid-normal range (500-700 ng/dL) 1.
- Complete blood count and prostate-specific antigen should be monitored periodically to watch for polycythemia and prostate issues 1.
- Patients should be aware that fertility may be reduced during treatment, and testicular atrophy can occur 1.
- Benefits typically include improved energy, libido, mood, and muscle mass, as reported in several studies 1.
- Treatment is generally lifelong as the body's natural testosterone production will decrease with exogenous testosterone administration, as noted in the evidence report by the American College of Physicians 1.
It's essential to weigh the potential benefits and risks of testosterone replacement therapy, considering the individual patient's needs and medical history, as emphasized in the guidelines by the Endocrine Society and American Urological Association 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 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. 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 patient's total testosterone level is 254 ng/dL. According to the normal range provided in the second drug label, the normal range for total testosterone is 222-800 ng/dL. Since the patient's level is within the normal range, testosterone replacement therapy is not recommended 2.
From the Research
Treatment Recommendation for Testosterone Replacement Therapy
The patient's total testosterone level is 254 ng/dL, which is below the normal physiologic range. According to the study 3, a physician should discuss the possibility of TRT with symptomatic patients who have a serum total testosterone level < 300 ng/dL.
Benefits and Risks of Testosterone Replacement Therapy
The evidence supporting TRT in improving body composition and sexual function is strong and consistent 3. However, the concern of some physicians about the potential for TRT to stimulate prostate cancer is not supported by decades of data accumulated to date 3.
Monitoring and Adjusting Testosterone Replacement Therapy
If TRT is initiated, a patient's response and adverse events should be assessed every 3 to 6 months, and therapy adjusted accordingly 3. The study 4 suggests that assessment of TRT with transdermal gels at its peak and at its minimum could be useful in providing a finely tailored treatment for hypogonadal men.
Response to Testosterone Replacement Therapy Based on Initial Serum Levels
The study 5 found that men with sexual symptoms of hypogonadism respond well to TRT across a wide range of initial TT values, including men with low-normal TT levels. The patient's initial serum level of 254 ng/dL falls into the range of 201-300 ng/dL, where 96.6% of men reported improvement in libido and 45.3% reported improvement in erectile function 5.
Key Considerations for Testosterone Replacement Therapy
- Patient preference, pharmacokinetics, potential for medication interactions, formulation-specific adverse effects, treatment burden, and cost should be considered when selecting a treatment method 6.
- Clinicians should monitor men receiving TRT for symptom improvement, potential adverse effects, and adherence 6.
- Serum testosterone, hematocrit, and prostate-specific antigen levels should be measured at baseline and at least annually in men 40 years or older receiving TRT 6.