What are the guidelines for Testosterone (Hormone Replacement Therapy) replacement?

From the Guidelines

Testosterone replacement therapy (TRT) should be considered for men with age-related low testosterone and sexual dysfunction who want to improve sexual function, after discussing the potential benefits, harms, costs, and patient's preferences, as recommended by the American College of Physicians 1. When considering TRT, it is essential to evaluate the patient's symptoms, medical history, and laboratory results to determine the underlying cause of hypogonadism.

• The American College of Physicians suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence) 1.
• The guidelines also recommend reevaluating symptoms within 12 months and periodically thereafter, and discontinuing testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence) 1.
• Additionally, the American College of Physicians 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. Some key points to consider when initiating TRT include:
• Monitoring testosterone levels, hematocrit, PSA, and lipid profile at 3,6, and 12 months after starting therapy, then annually 1.
• Targeting testosterone levels in the mid-normal range (400-700 ng/dL) 1.
• Contraindications for TRT include breast or prostate cancer, untreated severe sleep apnea, severe heart failure, or hematocrit above 54% 1. It is crucial to weigh the potential benefits and harms of TRT, including the risk of cardiovascular events, and to individualize treatment decisions based on each patient's unique needs and circumstances, as recommended by the FDA Safety Announcement 1.

From the FDA Drug Label

62% should be applied to clean, dry, intact skin of the upper arms and shoulders. The prescribed daily dose of testosterone gel 1.62% should be applied to the right and left upper arms and shoulders as shown in the shaded areas in Figure 1. Testosterone gel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. 5. 1 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH.

The guidelines for testosterone replacement therapy using testosterone gel 1.62% involve applying the gel to the upper arms and shoulders, with specific instructions for dosage and administration. Key considerations include:

• Applying the gel to clean, dry, intact skin
• Avoiding application to other parts of the body
• Following the prescribed daily dose and application sites
• Being aware of the potential risks, including worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer
• Taking precautions to minimize the potential for secondary exposure to testosterone, especially for children and women 2

From the Research

Testosterone Replacement Guidelines

• The evidence supporting testosterone replacement therapy (TRT) in improving body composition and sexual function is strong and consistent 3.
• TRT is recommended for symptomatic patients with a serum total testosterone level < 300 ng/dL, with regular assessments every 3 to 6 months to monitor response and adverse events 3.
• Selection of the testosterone replacement method depends on the patient's preference, with advice from the physician, and dose adjustment is possible with most delivery methods 4.
• Testosterone treatment can induce reversible suppression of spermatogenesis, and alternative treatments such as human chronic gonadotropin or selective estrogen receptor modulator may be used if fertility is desired 4.

Treatment Options

• Intramuscular testosterone cypionate (IM-TC) and subcutaneous testosterone enanthate autoinjector (SCTE-AI) are both effective testosterone delivery systems, but SCTE-AI may have a preferable safety profile due to lower levels of post-therapy estradiol and hematocrit 5.
• Testosterone replacement therapy can be administered via various methods, including intramuscular injections, subcutaneous injections, and topical gels or patches 4, 6.

Monitoring and Safety

• Regular monitoring of testosterone levels, hematocrit, and prostate-specific antigen (PSA) is recommended to ensure safe and effective treatment 3, 5, 7.
• Polycythemia is a potential side effect of testosterone replacement therapy, and regular blood tests are necessary to monitor for this condition 7.
• Testosterone replacement therapy appears to be well-tolerated by most patients, with improvements in libido and quality of life, but frequent follow-up blood tests and examinations are necessary to ensure safe treatment 7.