What is the treatment recommendation for a male, born 1971, with low total testosterone (Total Testosterone) level of 254, for testosterone replacement therapy?

From the Guidelines

Testosterone replacement therapy is recommended for this 53-year-old male with a total testosterone level of 254 ng/dL, which is below the normal range for adult men (typically 300-1000 ng/dL), but only if he has sexual dysfunction and wants to improve sexual function, as suggested by the American College of Physicians (ACP) 1. The most common treatment options include testosterone injections (such as testosterone cypionate 100-200mg intramuscularly every 1-2 weeks), daily transdermal gels (like AndroGel or Testim 50-100mg applied to shoulders, upper arms, or abdomen), or testosterone patches (like Androderm 4-6mg applied nightly). Some key points to consider when treating this patient include:

• Injections are cost-effective but cause fluctuating levels, while gels and patches provide more stable levels but are more expensive and may cause skin irritation.
• Before starting therapy, baseline PSA and hematocrit should be checked, with follow-up testing at 3-6 months to monitor testosterone levels, hematocrit, and PSA.
• Treatment goals include achieving mid-normal testosterone range (500-600 ng/dL) while monitoring for side effects like polycythemia, sleep apnea, or prostate issues.
• Lifestyle modifications including weight loss, regular exercise, and adequate sleep should complement medical therapy.
• The ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar 1.
• The ACP also suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter, and discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function 1.

From the FDA Drug Label

INDICATIONS AND USAGE Testosterone gel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired). Hypogonadotropic hypogonadism (congenital or acquired).

DOSAGE AND ADMINISTRATION 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.

The patient has a low total testosterone level of 254, which may indicate hypogonadism. The treatment recommendation for testosterone replacement therapy is to start with a dose of 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning, as indicated in the prescribing information for testosterone gel 1.62% 2.

• Key considerations:
  • 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.
  • Apply the gel to clean, dry, intact skin of the shoulders and upper arms.
  • Dose adjustment can be made based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment.
  • Patients should wash hands immediately with soap and water after applying testosterone gel 1.62% and cover the application site(s) with clothing after the gel has dried.
  • The safety and efficacy of testosterone gel 1.62% in men with “age-related hypogonadism” have not been established 2.

Given the patient's age (born 1971) and low total testosterone level, it is essential to carefully evaluate the diagnosis and consider the potential risks and benefits of testosterone replacement therapy. 2 3 4

From the Research

Testosterone Replacement Therapy

The patient, a male born in 1971 with a low total testosterone level of 254, may be a candidate for testosterone replacement therapy (TRT) if he exhibits symptoms of androgen deficiency 5, 6.

Diagnosis and Treatment

• The diagnosis of androgen deficiency should be made only in men with consistent symptoms and signs and unequivocally low serum testosterone levels 6.
• The initial diagnostic test should be the measurement of morning total testosterone level by a reliable assay 6.
• Testosterone therapy is recommended for symptomatic men with androgen deficiency, who have low testosterone levels, to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density 5, 6.

Treatment Options

• Available testosterone treatment modalities include intramuscular injections, nongenital patch or gel, bioadhesive buccal and oral testosterone, and pellets 5.
• Transdermal application of testosterone gels are the most commonly used route of testosterone administration 7.
• The goal of all available testosterone treatment modalities is to achieve serum testosterone levels in the mid-normal range during treatment 5, 6.

Monitoring and Contraindications

• Men receiving testosterone therapy should be monitored using a standardized plan 6.
• Testosterone replacement is not recommended for all older men with low testosterone levels, and should be avoided in patients with prostate or breast cancer, hyperviscosity, erythrocytosis, untreated obstructive sleep apnea, or severe heart failure 5, 6.