Testosterone Undecanoate Therapy for Hypogonadism
Monitoring and Safety
- Measure testosterone levels 2-3 months after treatment initiation and after any dose or interval change, with a target of mid-normal testosterone values (500-600 ng/dL or 14-17.5 nmol/L) measured as trough levels before the next injection, as recommended by the American College of Physicians, with a strength of evidence of high 1, 2
- Monitor hematocrit periodically and withhold treatment if >54%, as intramuscular testosterone carries a higher erythrocytosis risk, with a strength of evidence of moderate 1, 3
- Check PSA in men over 40 years and adjust treatment if significant increases occur, with a strength of evidence of low 1
- Assess for benign prostatic hyperplasia symptoms through prostate examination, with a strength of evidence of low 1
Contraindications and Precautions
- Absolute contraindications for testosterone undecanoate therapy include active male breast cancer and men actively seeking fertility, as testosterone suppresses spermatogenesis, with a strength of evidence of high 1
- The oral formulation of testosterone undecanoate is specifically contraindicated by the FDA for age-related hypogonadism not associated with structural or genetic etiologies, with a strength of evidence of high 4