Objective:

To update the prescribing information for testosterone replacement therapy products based on new clinical data and scientific evidence.

Approach:

Key Findings:

• The TRAVERSE trial found no meaningful increase in the risk of major adverse cardiovascular events among men receiving testosterone replacement therapy.
• Current data do not generally show an increased risk of prostate cancer in men receiving testosterone replacement therapy.
• Available clinical trial data do not demonstrate worsening symptoms of benign prostatic hyperplasia in men with mild to moderate conditions.

Interpretation:

Limitations:

• Uncertainties remain regarding the long-term effects of testosterone therapy on prostate cancer risk.
• Existing studies may not have followed patients long enough to detect long-term effects.

Conclusion:

Attribution Notice

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