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Oral testosterone therapy: past, present, and future.

Jake A Miller1, Tuan T Nguyen1, Charles Loeb1

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Oral testosterone undecanoate (oTU) effectively improved testosterone levels in hypogonadal men without significant adverse effects. However, it did not consistently increase testosterone in eugonadal men.

Keywords:
hormone replacement therapyhypogonadismtestosteronetestosterone undecanoate

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Testosterone replacement therapy (TRT) is a common treatment for testosterone deficiency (TD).
  • New oral TRT medications face scrutiny regarding efficacy and safety, impacting prescription rates.
  • Oral testosterone undecanoate (oTU) is a novel oral TRT option requiring thorough evaluation.

Approach:

  • A systematic literature review was conducted using Medline, EMBASE, and Cochrane Library databases.
  • 1269 articles were identified, with 44 included for review and 12 used for meta-analyses.
  • The review assessed serum total testosterone (TT) changes, adverse effects, and impacts on body composition, liver function, and other health markers.

Key Points:

  • Meta-analyses showed no significant increase in TT with oTU versus placebo overall.
  • oTU significantly decreased TT in eugonadal participants but increased it in hypogonadal participants.
  • No significant increase in overall or serious adverse effects was observed with oTU compared to placebo.

Conclusions:

  • oTU is well-tolerated in hypogonadal patients, improving testosterone levels and symptoms without significant toxicity.
  • Effects of oTU on body composition, hematologic assays, lipid profiles, and well-being lack consistent findings.
  • oTU demonstrates potential as a safe and effective oral TRT for hypogonadal men.