When is treatment with testosterone indicated?

From the Guidelines

Testosterone treatment is indicated for men with confirmed testosterone deficiency, also known as hypogonadism, who have both low testosterone levels on blood tests (typically below 300 ng/dL when measured in the morning on at least two occasions) and clinical symptoms. These symptoms include decreased libido, erectile dysfunction, fatigue, depressed mood, reduced muscle mass, increased body fat, decreased bone density, and cognitive difficulties.

Key Considerations for Testosterone Treatment

• Testosterone therapy may be prescribed as injections (such as testosterone cypionate 50-400mg every 1-4 weeks), transdermal gels or patches (typically 50-100mg daily), subcutaneous pellets, or buccal tablets.
• Treatment is typically lifelong for primary hypogonadism (testicular failure) but may be temporary for secondary causes.
• Before starting treatment, patients should undergo prostate cancer screening with PSA testing and digital rectal examination.
• Testosterone therapy is contraindicated in men with breast or prostate cancer, untreated severe sleep apnea, severe heart failure, or elevated hematocrit.
• Regular monitoring during treatment includes testosterone levels, hematocrit, liver function, lipid profile, and prostate health, as supported by recent guidelines 1.

Evidence Supporting Testosterone Treatment

The American College of Physicians has published guidelines on the efficacy and safety of testosterone treatment in men, highlighting its benefits for sexual functioning and quality of life in men with low testosterone levels 1. Additionally, studies have shown that testosterone replacement therapy can improve metabolic parameters, such as weight loss, fasting plasma glucose, and insulin resistance, in men with obesity and hypogonadism 1. However, the long-term efficacy and safety of testosterone treatment are unknown, and its use should be carefully considered and monitored 1.

Important Safety Considerations

The FDA has required a labeling change to inform healthcare professionals and patients of a possible increased risk of heart attack and stroke with the use of testosterone preparations to treat age-related hypogonadism 1. Therefore, it is essential to weigh the potential benefits and risks of testosterone treatment for each individual patient and to closely monitor their health during treatment.

From the FDA Drug Label

INDICATIONS AND USAGE Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Treatment with testosterone is indicated for:

• Replacement therapy in males with conditions associated with symptoms of deficiency or absence of endogenous testosterone.
• Primary hypogonadism (congenital or acquired) due to testicular failure.
• Hypogonadotropic hypogonadism (congenital or acquired) due to idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation 2.
• Delayed puberty in carefully selected males with clearly delayed puberty 3.
• Metastatic mammary cancer in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal 3.

From the Research

Indications for Testosterone Treatment

Testosterone treatment is indicated for men with hypogonadism, a condition characterized by inadequate testosterone production. The following are some key points to consider:

• Hypogonadism can be primary (hypergonadotropic) or secondary (hypogonadotropic), and testosterone replacement therapy (TRT) is a crucial intervention for men diagnosed with this condition 4.
• The diagnosis of hypogonadism is based on clinical signs and symptoms, plus laboratory confirmation via the measurement of low morning testosterone levels on two different occasions 5.
• Testosterone therapy is the treatment of choice to induce and maintain secondary sexual characteristics and sexual function in men with hypogonadotropic hypogonadism, especially if fertility is not an issue 6.
• TRT can have many potential benefits, including improved sexual function, an enhanced sense of well-being, increased lean body mass, decreased body fat, and increased bone density 5.

Considerations for Treatment

When considering testosterone treatment, the following points are important:

• The benefits of androgen therapy outweigh the risks in men with classic hypogonadism, but for men with mild hypogonadism or andropause, the balance between benefits and risks is not always clear 5.
• Testosterone treatment induces reversible suppression of spermatogenesis, and if fertility is desired in the near future, alternative treatments such as human chorionic gonadotropin, selective estrogen receptor modulator, estrogen antagonist, or an aromatase inhibitor may be used 7, 8.
• The selection of testosterone replacement method depends on the patient's preference with advice from the physician, and dose adjustment is possible with most delivery methods 7.