What is the recommended testosterone replacement therapy dosing via transdermal patch for a 35-year-old male with hypogonadism (low testosterone levels) and a z score of -2.8?

From the Guidelines

For a 35-year-old male with hypogonadism and a z-score of -2.8, the recommended testosterone replacement therapy using transdermal patches is typically 2-6 mg applied daily, as indicated in the study by 1. The treatment should begin with a 2 mg patch applied each evening to clean, dry skin on the back, abdomen, upper arms, or thighs, rotating application sites to prevent skin irritation.

• The patch should remain in place for 24 hours.
• Dose adjustments may be necessary based on serum testosterone levels, which should be monitored after 2-4 weeks of therapy, aiming for levels in the mid-normal range (400-700 ng/dL).
• The severe deficiency indicated by the z-score of -2.8 suggests the need for consistent therapy, with clinical response typically observed within 3-6 months. Some key considerations for the application of transdermal patches include:
• Patients should be advised that patches must be applied to areas without excessive hair.
• Avoid application to the scrotum or bony areas. Regular monitoring of hematocrit, PSA, and liver function is necessary during treatment, with clinical evaluations recommended every 3-6 months during the first year and annually thereafter to assess symptom improvement and potential side effects, as suggested by the information provided in the study 1.

From the FDA Drug Label

2.1 Dosing and Dose Adjustment The recommended starting dose of testosterone gel, 1.62% is 40.5 mg of testosterone (2 pump actuations) 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 Table 1 describes the dose adjustments required at each titration step. Table 1: Dose Adjustment Criteria Pre-Dose Morning Total Serum Testosterone Concentration Dose Titration Greater than 750 ng/dL Decrease daily dose by 20.25 mg (1 pump actuation) 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)

The patient has a testosterone level of 215, which is below the normal range.

• The recommended starting dose is 40.5 mg of testosterone (2 pump actuations) applied topically once daily.
• Since the patient's testosterone level is less than 350 ng/dL, the dose may need to be adjusted based on the patient's response to treatment.
• The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations) 2.

From the Research

Testosterone Replacement Therapy via Transdermal Patch

The recommended testosterone replacement therapy dosing via transdermal patch for a 35-year-old male with hypogonadism and a z score of -2.8 is not explicitly stated in the provided studies. However, the following information can be gathered:

• Transdermal testosterone patches can provide for physiologic androgen replacement in over 90% of men with hypogonadism 3.
• The normal circadian rhythm of testosterone levels can be restored with daily use of transdermal testosterone patches 3.
• Testosterone is necessary to induce and maintain secondary sexual characteristics, lean muscle mass, bone density, and for normal sexual behavior and cognitive function in men 4.
• The current experience with the use of various forms of testosterone for the treatment of male hypogonadism is reviewed, including transdermal patches, gels, and intramuscular preparations 4, 5.

Key Considerations

• The diagnosis of hypogonadism includes both clinical history and examination as well as biochemical assessment of serum testosterone levels 6.
• Total testosterone levels of less than 8 nmol/l highly support a diagnosis of hypogonadism, whereas levels greater than 12 nmol/l are likely to be normal 6.
• A trial period of testosterone treatment may be required for patients with testosterone levels in the grey zone between 8 and 12 nmol/l 6.
• Transdermal testosterone gels have emerged as a favorable mode of testosterone substitution, with a pharmacokinetic profile comparable to that of testosterone patches 7.

Available Formulations and Dosage

• Transdermal testosterone patches are available, but the dosage is not specified in the provided studies.
• Testosterone gels are available, with a recommended dosage that is not specified in the provided studies.
• The formulations currently available on the market are generally expensive, and dose adjustment protocols for each differ 5.