New studies, especially the TRAVERSE trial, are reshaping our understanding of testosterone therapy (TT), challenging long-standing concerns about its cardiovascular and prostate risks. The FDA updated the labelling for testosterone products in February 2025, removing warnings about increased cardiovascular risks.
Key Findings:
1. Cardiovascular Risk
- TRAVERSE trial and Androgen Society: Testosterone therapy does not increase the risk of major adverse cardiovascular events (MACE) or venous thromboembolism.
- It may even reduce MACE risk.
2. Prostate Health
- An analysis of prostate cancer data from the TRAVERSE trial compared the effects of testosterone therapy with placebo on the incidence of prostate outcomes.
- No significant difference between testosterone and placebo groups in:
- High-grade or any prostate cancer
- Number of prostate biopsies
- Surgeries or pharmacologic treatment for benign prostatic hyperplasia (BPH)
3. Blood Pressure
- Testosterone undecanoate therapy significantly reduced systolic and diastolic blood pressure, especially in men with higher baseline BP.
- These effects occurred regardless of antihypertensive medication use.
4. Mortality
- A real-world study showed 59% lower mortality in treated men vs untreated men with low testosterone.
- Benefits were independent of diabetes status and included improvements in:
- Waist size
- A1c
- Lipids
- Blood pressure
- Benefits were independent of diabetes status and included improvements in:
- Finnish Randomized Study of Screening for Prostate Cancer study showed reductions in:
- Cardiovascular mortality by 13%
- All-cause mortality by 7%
- Prostate cancer mortality by 48%
5. Liver Disease (MASLD)
- EARTH study: 12 months of TT improved Fibrosis-4 index in hypogonadal men with elevated baseline levels.
- Testosterone therapy improved:
- Liver steatosis and fibrosis
- Liver enzymes (ALP, ALT, AST, GGT)