Testosterone Therapy: A New Era of Confidence and Clarity

In a significant development for men’s health, the FDA has removed the black box warning concerning cardiovascular risks from all testosterone therapy products. This decision, announced in early 2025, follows the results of the TRAVERSE trial—a comprehensive study involving over 5,000 men with hypogonadism—which found no increased risk of major cardiovascular events associated with testosterone therapy.   


Understanding the Change
The black box warning, previously the FDA’s most stringent caution, was based on earlier studies suggesting potential heart-related risks with testosterone therapy. However, the TRAVERSE trial provided robust evidence that, when prescribed appropriately, testosterone therapy does not elevate the risk of heart attacks or strokes.


Benefits of Testosterone Therapy
For men diagnosed with low testosterone levels, therapy can offer several health benefits:
    •    Enhanced Energy Levels: Many men report reduced fatigue and increased vitality. 
   •  Improved Mood: Testosterone therapy can alleviate symptoms of depression and irritability.
    •    Increased Muscle Mass and Bone Density: Therapy supports physical strength and reduces the risk of osteoporosis.
  • Better Sexual Function: Men often experience improved libido and sexual performance.


The benefit's of TRT are not only physical, but mental as well. Studies have also shown benefits to help with resilience towards PTSD and anxiety. However, it’s crucial to note that these benefits are most pronounced when therapy is administered under medical supervision, with regular monitoring to ensure optimal hormone levels and minimize potential side effects.