What are the indications for Androgel (testosterone)?

From the Guidelines

AndroGel is indicated for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism, as supported by the most recent evidence from 2020 1, 2. The conditions that AndroGel is indicated for include:

• Primary hypogonadism (congenital or acquired)
• Hypogonadotropic hypogonadism (congenital or acquired) AndroGel comes in two strengths: 1% and 1.62%. The typical starting dose for AndroGel 1% is 5 grams (50 mg testosterone) applied once daily to clean, dry skin of the shoulders, upper arms, or abdomen. For AndroGel 1.62%, the starting dose is 40.5 mg (2.5 grams) applied once daily. Dosage can be adjusted based on serum testosterone levels, with a maximum daily dose of 10 grams for the 1% formulation and 81 mg (5 grams) for the 1.62% formulation. The gel should be allowed to dry completely before dressing and patients should wash hands thoroughly after application. It's essential to avoid skin-to-skin contact with others, especially women and children, at the application site to prevent testosterone transfer, as noted in the study from 2017 3. AndroGel works by providing exogenous testosterone that is absorbed through the skin into the bloodstream, compensating for the body's inability to produce adequate amounts naturally, thus alleviating symptoms of testosterone deficiency such as fatigue, decreased libido, and reduced muscle mass. The evidence from 2020 suggests that testosterone treatment may provide small improvements in sexual functioning and quality of life but little to no benefit for other common symptoms of aging 1. Additionally, the guideline from 2020 recommends that clinicians discuss the potential benefits and harms of testosterone treatment with patients and consider their individual preferences and values when making treatment decisions 2.

From the FDA Drug Label

1 INDICATIONS AND USAGE 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 These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.

The indications for Androgel (testosterone gel, 1.62%) are:

• Primary hypogonadism (congenital or acquired)
• Hypogonadotropic hypogonadism (congenital or acquired) 4

From the Research

Androgel Indications

• Androgel is indicated for the treatment of hypogonadal men, with the goal of normalizing serum testosterone levels and improving symptoms such as sexual dysfunction and low mood 5.
• The treatment has been shown to have beneficial effects on lean and fat mass, bone mineral density, and overall quality of life in hypogonadal men 5.
• Androgel can be used as an alternative to injectable androgens, with the advantage of transdermal delivery 5.
• The indications for Androgel are not limited to hypogonadal men, but also include men with secondary hypogonadism, such as those with pituitary or hypothalamic dysfunction 6, 7.

Hypogonadism Diagnosis and Treatment

• The diagnosis of hypogonadism requires a comprehensive health history, evaluation of signs and symptoms, complete physical examination, and laboratory and diagnostic testing 8.
• Hormone replacement therapy, including Androgel, is the hallmark of hypogonadism treatment, with the goal of restoring and maintaining quality of life 8.
• The Endocrine Society of Australia recommends testosterone replacement therapy for men with pathological hypogonadism, regardless of age 6.
• However, the use of testosterone therapy in older men with low circulating testosterone levels but without hypothalamic, pituitary, or testicular disease is not supported by high-quality evidence 6.

Androgel Efficacy and Safety

• Androgel has been shown to be effective in improving sexual function, mood, and bone mineral density in hypogonadal men 5.
• The treatment has also been shown to increase lean body mass and decrease fat mass, although the changes in muscle strength were not significant 5.
• Common side effects of Androgel include mild local skin irritation, and monitoring for prostatic disease and erythrocytosis is recommended to reduce the risk of adverse events 5, 9.