What are the indications for Testosterone (T) replacement therapy?

From the Guidelines

Testosterone replacement therapy is indicated for men with primary or secondary hypogonadism caused by disorders of the hypothalamus, pituitary gland, or testes, often classified as organic or classical hypogonadism, as stated by the FDA and supported by the American College of Physicians 1. This indication is based on the standard care for the development or maintenance of secondary sexual characteristics in men with these conditions. The use of testosterone therapy in men without established conditions that cause permanent testicular or hypothalamic–pituitary dysfunction is not well-supported by evidence, and its efficacy and safety are unknown in the long term 1. Some key points to consider when evaluating the indications for testosterone replacement therapy include:

• The level of baseline testosterone that prompts initiation of therapy varies widely, and substantial proportions of men who receive testosterone therapy do not have testosterone levels tested before initiation of therapy 1.
• Testosterone treatment may provide small improvements in sexual functioning and quality of life in older men with low testosterone levels without well-established medical conditions known to cause hypogonadism, but little to no benefit for other common symptoms of aging 1.
• The FDA has approved testosterone treatment for replacement therapy in men with primary or secondary hypogonadism caused by disorders of the hypothalamus, pituitary gland, or testes 1. It is essential to carefully evaluate the indications for testosterone replacement therapy and to consider the potential benefits and harms of treatment in individual patients, as supported by the highest quality evidence available 1.

From the FDA Drug Label

Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation 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.

The indications for Testosterone (T) replacement therapy are:

• Primary hypogonadism (congenital or acquired)
• Hypogonadotropic hypogonadism (congenital or acquired) These conditions are associated with a deficiency or absence of endogenous testosterone, and testosterone replacement therapy is used to treat the symptoms of these conditions 2, 2, 3.

From the Research

Indications for Testosterone Replacement Therapy

The indications for testosterone replacement therapy (TRT) are based on the presence of symptoms of androgen deficiency and low serum testosterone levels. The following are the indications for TRT:

• Hypogonadism, including primary, secondary, and late-onset hypogonadism 4
• Symptoms of testosterone deficiency, such as decreased libido, erectile dysfunction, and depressed mood 5
• Low serum testosterone levels, which can be diagnosed through blood tests 4, 6
• Presence of comorbidities, such as obesity, metabolic syndrome, type 2 diabetes mellitus, and osteoporosis, which can be improved with TRT 4, 6

Patient Selection

Patient selection for TRT is crucial, and the following factors should be considered:

• Presence of symptoms of androgen deficiency and low serum testosterone levels 4, 6
• Patient's preference and advice from the physician 7
• Presence of comorbidities and potential risks associated with TRT, such as cardiovascular disease, prostate cancer, and sleep apnea 6, 5

Monitoring and Treatment

Monitoring and treatment of patients on TRT should include:

• Regular measurement of serum testosterone levels, haemoglobin, and haematocrit 4
• Surveillance of well-being, libido, and sexual activity 4
• Regular digital rectal examination and measurement of prostate-specific antigen (PSA) 4
• Biannual measurement of bone mineral density 4
• Scheduled testing for adverse events, such as cardiovascular disease, prostate cancer, and sleep apnea 6, 5