From the Guidelines
Testosterone therapy is indicated for men with confirmed hypogonadism, characterized by low serum testosterone levels (typically below 300 ng/dL) along with symptoms such as decreased libido, erectile dysfunction, fatigue, reduced muscle mass, increased body fat, decreased bone density, and mood disturbances. Primary indications include primary hypogonadism (testicular failure), secondary hypogonadism (pituitary or hypothalamic dysfunction), and delayed puberty in males. Common testosterone preparations include injectable testosterone cypionate or enanthate (50-400 mg every 2-4 weeks), transdermal patches (2-6 mg/day), topical gels (50-100 mg daily), and subcutaneous pellets (150-450 mg every 3-6 months) 1.
Before initiating therapy, patients should undergo baseline assessment including prostate-specific antigen (PSA), hematocrit, and lipid profile. Testosterone therapy works by replacing deficient hormone levels, thereby restoring physiologic functions dependent on adequate androgen levels. Treatment is contraindicated in men with breast or prostate cancer, untreated severe sleep apnea, severe lower urinary tract symptoms, erythrocytosis (hematocrit >54%), or those desiring fertility, as exogenous testosterone suppresses spermatogenesis 1.
Some key points to consider when initiating testosterone therapy include:
- The potential benefits, harms, costs, and patient's preferences should be taken into account 1
- Clinicians should reevaluate symptoms within 12 months and periodically thereafter, and discontinue testosterone treatment if there is no improvement in sexual function 1
- Intramuscular formulations may be preferred over transdermal formulations due to lower costs and similar clinical effectiveness and harms 1
- Testosterone therapy may provide small improvements in sexual functioning and quality of life, but little to no benefit for other common symptoms of aging 1
It is essential to note that long-term efficacy and safety of testosterone therapy are unknown, and more research is needed to fully understand its effects 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). (1) Hypogonadotropic hypogonadism (congenital or acquired). (1) 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. 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). (1) Hypogonadotropic hypogonadism (congenital or acquired). (1)
The indications to start testosterone are:
- Primary hypogonadism (congenital or acquired) 2, 3, 2
- Hypogonadotropic hypogonadism (congenital or acquired) 2, 3, 2 Key considerations before initiating testosterone therapy include:
- Confirming the diagnosis of hypogonadism by measuring serum testosterone levels on at least two separate days 2
- Evaluating the patient's medical history and current health status to ensure safe use of testosterone 2, 3
From the Research
Indications for Testosterone Replacement Therapy
The decision to start testosterone replacement therapy (TRT) is based on several factors, including the presence of hypogonadism, low testosterone levels, and symptoms associated with testosterone deficiency.
- Hypogonadism is a condition characterized by inadequate testosterone production, which can be due to primary hypogonadism (testicular failure) or secondary hypogonadism (hypothalamic-pituitary dysfunction) 4, 5.
- Testosterone deficiency is defined as a serum level less than 300 ng/dL on a morning total testosterone test, and it is estimated that more than one-third of men 45 years and older have testosterone deficiency 5.
- Symptoms associated with testosterone deficiency include decreased libido, erectile dysfunction, decreased physical stamina and strength, depressed mood, fatigue, increased visceral adiposity, sleep disturbance, and/or poor concentration and memory 5, 6.
Diagnostic Criteria
The diagnosis of hypogonadism is based on a combination of clinical evaluation, medical history, and laboratory tests.
- Laboratory tests include measurement of serum testosterone levels, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) levels 7.
- A serum total testosterone level < 300 ng/dL is considered low, and TRT may be recommended for symptomatic patients with this level 6.
Treatment Options
TRT is a crucial intervention for men diagnosed with hypogonadism, and the goal of treatment is to restore normal serum testosterone concentrations and relieve symptoms.