The TRAVERSE Trial Changed Everything
For years, the biggest fear around TRT was cardiovascular risk. The landmark TRAVERSE trial (2023) — a randomized controlled study of 5,246 men — found no increase in major adverse cardiac events with TRT compared to placebo. The study also showed a 22% lower rate of new-onset diabetes in the TRT group.
A 2015 study of 83,010 male veterans found that normalization of testosterone was associated with 56% lower mortality, 24% fewer heart attacks, and 36% fewer strokes.
Common Side Effects
Like any medical treatment, TRT has potential side effects — most of which are manageable with proper monitoring. Polycythemia (elevated red blood cells) is the most common, occurring in roughly 5-10% of patients. Regular CBC monitoring catches this early, and dose adjustment or therapeutic phlebotomy resolves it. Acne and oily skin may occur as sebaceous gland activity increases. Fluid retention is usually mild and self-limiting. Mood changes are rare and more often associated with supraphysiological dosing than therapeutic replacement.
Prostate Health
The historical belief that testosterone "feeds" prostate cancer has been thoroughly re-examined. In December 2025, an FDA expert panel recommended removing the prostate cancer warning from TRT labels, citing it as unsupported by contemporary evidence. The TRAVERSE trial and multiple large-scale studies found no increased prostate cancer risk with TRT in properly screened men.
That said, TRT is still contraindicated in men with active, untreated prostate cancer. Regular PSA monitoring remains standard protocol.
Fertility Considerations
This is perhaps the most important safety consideration for younger men. Exogenous testosterone suppresses the HPG axis, which can significantly reduce or eliminate sperm production. This effect is usually reversible after stopping TRT, but recovery can take 6-12 months and isn't guaranteed.
If fertility preservation matters to you, discuss options with your provider before starting TRT. Alternatives include clomiphene citrate (stimulates natural production), HCG co-therapy (maintains testicular function), or sperm banking before starting treatment.
The FDA is no longer treating testosterone as if it were a dangerous performance-enhancing drug from the 1980s. The evidence supports responsible use with proper monitoring.