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Reflections on the T Trials.

Ronald Swerdloff1, Christina Wang1,2

  • 1Division of Endocrinology, Department of Medicine, The Lundquist Institute and Harbor-UCLA Medical Center, Torrance, CA, USA.

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|September 9, 2020
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Summary
This summary is machine-generated.

Testosterone replacement therapy in older men showed benefits in sexual function, bone health, and anemia, with modest improvements in vitality. However, no cognitive benefits were observed, and cardiovascular outcomes were negative in exploratory trials.

Keywords:
anemiabone healthlate-onset hypogonadismphysical functionsexual functiontestosterone

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Area of Science:

  • Endocrinology
  • Geriatrics
  • Clinical Trials

Background:

  • Review of the T Trials, a series of placebo-controlled studies on testosterone replacement therapy (TRT) in older men with hypogonadism.
  • Focus on re-examining efficacy in men over 65 years old.

Purpose of the Study:

  • To re-evaluate the effectiveness of testosterone replacement therapy in hypogonadal men aged 65 and older, based on the T Trials data.
  • To discuss the findings within the context of late-onset hypogonadism.

Main Methods:

  • Analysis of seven double-blind, placebo-controlled trials (T Trials) involving 788 men with low testosterone and hypogonadism symptoms.
  • Included three main trials (sexual function, physical function, vitality) and four sub-trials (cognition, bone, anemia, cardiovascular).
  • Exclusion criteria targeted men at higher risk for prostate cancer or recent cardiovascular events.

Main Results:

  • Positive outcomes reported for sexual function, bone density, and anemia.
  • Modest benefits observed in vitality; partial benefits in physical function.
  • No benefits in cognition trials; negative findings in the exploratory cardiovascular trial (underpowered).
  • Adverse events were infrequent, with erythrocytosis being the most common testosterone-related side effect.

Conclusions:

  • Testosterone replacement therapy demonstrated efficacy in improving sexual function, bone health, and anemia in older hypogonadal men.
  • The T Trials indicated mixed results across different domains, with no cognitive improvement and concerning cardiovascular findings.
  • The studies were not designed to assess long-term safety risks associated with testosterone therapy.