From the Guidelines
Testosterone levels in males should be evaluated and treated based on symptoms and laboratory results, with consideration of morning total testosterone concentration, free testosterone level, and sex hormone-binding globulin level, particularly in patients with obesity. When evaluating testosterone levels, it is essential to consider the normal total testosterone range for adult men, which is 300 to 800 ng/dL in most laboratories 1. Symptoms of low testosterone include decreases in energy, libido, muscle mass, and body hair, as well as hot flashes, gynecomastia, and infertility. Key points to consider when evaluating and treating low testosterone levels include:
- Measuring morning serum free testosterone is essential in men with obesity to distinguish between low total testosterone due to low sex hormone-binding globulin and frankly low free testosterone levels 1.
- Testosterone replacement therapy has demonstrated favorable results in men with obesity and hypogonadism, including weight loss, improvements in fasting plasma glucose, insulin resistance, and lipid profiles 1.
- The most common method of testosterone replacement is as a topical preparation, with transdermal testosterone preparations (gel, patch) favored over intramuscular injections due to the relative stability of testosterone levels and avoidance of discomfort 1.
- Treatment with testosterone-replacement therapy should be considered when the morning free testosterone by equilibrium dialysis is frankly low on at least 2 separate assessments, and the hypogonadism workup has been completed to rule out an etiology of hypogonadism unrelated to obesity 1.
- Patients should be monitored to determine that normal serum testosterone concentrations are being achieved, with testosterone levels tested 2 to 3 months after treatment initiation, and/or after any dose change 1. It is crucial to individualize the method of testosterone replacement for each patient, considering factors such as personal disease-management skills, resources, and potential side effects 1.
From the FDA Drug Label
Testosterone gel 1.62% delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal levels (300 ng/dL to 1000 ng/dL) seen in healthy men. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. The primary endpoint was the percentage of patients with Cavg within the normal range of 300 ng/dL to 1000 ng/dL on Day 112. In patients treated with testosterone gel 1.62%, 81.6% (146/179) had Cavg within the normal range at Day 112.
Normal Testosterone Levels in Males: The normal testosterone levels in males are between 300 ng/dL to 1000 ng/dL.
- The testosterone gel 1.62% delivers physiologic amounts of testosterone to produce circulating testosterone concentrations within this range.
- The primary endpoint of a clinical study showed that 81.6% of patients treated with testosterone gel 1.62% had average testosterone concentrations (Cavg) within the normal range on Day 112. 2 2
From the Research
Testosterone Levels in Males
- Testosterone levels in males can be affected by various factors, including age, health conditions, and lifestyle choices 3, 4, 5, 6, 7
- Male hypogonadism, a condition characterized by low testosterone levels, can be diagnosed through laboratory tests, including measurement of morning testosterone levels on two different occasions 3, 4
- The diagnosis of hypogonadism should be based on clinical signs and symptoms, as well as laboratory confirmation of low testosterone levels 4
Causes and Symptoms of Low Testosterone
- Low testosterone levels can be caused by primary (hypergonadotropic) or secondary (hypogonadotropic) hypogonadism, as well as hypogonadism associated with aging (andropause) 3
- Symptoms of low testosterone include decreased libido, erectile dysfunction, decreased muscle mass, and decreased bone density 3, 7
- Adult-onset hypogonadism (AOH) is a syndrome that occurs in middle-age and older men, characterized by low testosterone levels and associated signs and symptoms, accompanied by low or normal gonadotropin levels 6
Treatment Options for Low Testosterone
- Androgen replacement therapy, including testosterone injections, transdermal therapies, and oral formulations, can be used to treat hypogonadism in men 3, 4, 5
- The goal of treatment is to induce and maintain secondary sex characteristics, correct symptoms of hypogonadism, and improve quality of life 4, 7
- New oral formulations, such as JATENZO and TLANDO, have been approved by the US Food and Drug Administration and offer a safe and convenient treatment option for men with hypogonadism 5
Monitoring and Follow-up
- Men receiving testosterone therapy should be monitored regularly to evaluate symptoms, adverse effects, and compliance, as well as to measure serum testosterone and hematocrit concentrations 4
- Prostate cancer risk should be evaluated during the first year after initiating testosterone therapy, and annual prostate cancer screening can be offered to patients after a discussion of its risks and benefits 3, 4