Testosterone therapy is FDA approved specifically for men who have a medical condition called hypogonadism, which means their bodies do not produce enough testosterone naturally. This approval is not based on aging alone but on documented low testosterone levels combined with symptoms related to testosterone deficiency. The FDA has approved various forms of testosterone replacement therapy (TRT), including injections, gels, patches, and more recently, oral capsules like KYZATREX, for treating men with clinically low testosterone levels confirmed by lab tests.
Aging in men often leads to a natural decline in testosterone levels, sometimes called “age-related low testosterone” or “andropause.” However, the FDA does not broadly approve testosterone therapy simply for aging or the natural decline in testosterone that comes with getting older. Instead, therapy is indicated when men have symptoms consistent with testosterone deficiency and consistently low testosterone levels measured on two separate mornings, typically below 300 ng/dL.
Recent clinical trials, such as the landmark TRAVERSE trial, have significantly influenced the safety profile and regulatory stance on testosterone therapy. This large study showed that testosterone replacement in men with hypogonadism and cardiovascular risk factors did not increase the risk of major cardiac events compared to placebo. This finding led to the removal of previous FDA cardiovascular warnings on testosterone products, marking a major shift in how testosterone therapy is viewed in terms of safety. However, the FDA still requires careful patient selection and monitoring, including screening for prostate cancer and monitoring blood pressure, as testosterone therapy can raise blood pressure in some men.
The FDA approval process ensures that testosterone therapies meet strict standards for safety, efficacy, and manufacturing quality. Traditional testosterone therapies, such as testosterone cypionate injections and topical gels, have decades of data supporting their use in men with hypogonadism. More recently, oral testosterone therapies like KYZATREX have been approved, offering a convenient alternative with a well-established safety profile. These therapies are prescribed by healthcare providers after thorough evaluation, including symptom assessment and blood tests.
It is important to understand that testosterone therapy is not a fountain of youth or a treatment for normal aging. It is a medical treatment for men who have a diagnosed hormone deficiency. Using testosterone therapy without documented low levels or for general anti-aging purposes is not FDA approved and may carry risks without proven benefits. The therapy requires ongoing monitoring to ensure safety and effectiveness, including watching for side effects such as increased red blood cell count, changes in prostate-specific antigen (PSA) levels, and cardiovascular parameters.
In summary, testosterone therapy is FDA approved for men with hypogonadism, a condition of low testosterone production, but not simply for aging-related testosterone decline. The approval covers multiple delivery methods, and recent research has improved the understanding of its safety, especially regarding cardiovascular and prostate health. Men considering testosterone therapy should undergo proper medical evaluation and receive treatment only if they meet the criteria for testosterone deficiency, with careful monitoring throughout therapy.
