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Testosterone and Aging Clinical Research Directions (2004) / Chapter Skim
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Executive Summary
Pages 1-10

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From page 1...
... asked the Institute of Medicine (IOM) to conduct a 12-month study to review and assess the current state of knowledge related to the potential beneficial and adverse health effects of testosterone therapy in older men, and to make recommendations regarding clinical trials of testosterone therapy, including the parameters that should be considered in study design and conduct.
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From page 2...
... CLINICAL TRIALS OF TESTOSTERONE THERAPY IN OLDER MEN Before weighing the options for future research directions, the committee reached several general conclusions that serve as the rationale for its recommendations (Box ES-1. The committee felt that the first and most immediate goal is to establish whether treatment with testosterone results in clear benefits in aging men.
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From page 3...
... Overview of Recommended Clinical Trials In implementing the general conclusions and rationale discussed above, the committee encourages clinical research efforts to initially focus
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From page 4...
... Conduct Clinical Trials in OlderMen. The committee recommends that the National Institute on Aging and other research agencies and institutions conduct clinical trials of testosterone therapy in older men with low testosterone levels.
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From page 5...
... The committee recommends: Strict exclusion criteria, such as for men who are at high risk for developing prostate cancer or for requiring an intervention to treat benign prostatic hyperplasia (BPH) ; Careful participant monitoring for changes in prostate specific antigen (PSA)
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From page 6...
... Conduct Further Research. In addition to the research strategy for clinical trials recommended above, the committee recommends further investigator-initiated research on such issues as physiologic regulation of endogenous testosterone levels, mechanism of action of testosterone, and age-related changes in testosterone levels.
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From page 7...
... Experience with the use of postmenopausal hormone therapy in women and the growing body of scientific evidence about its risks and potential benefits provides an apt and timely example of the need for sustained, systematic analysis of short- and long-term effects of new treatments and the caution that must be exercised in widely prescribing drugs as preventive measures. Clearly, empirical evidence about testosterone therapy is needed.
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Key Terms

  • clinical trials
  • testosterone levels
  • prostate cancer
  • low testosterone
  • conduct clinical

  • exclusion criteria
  • efficacy trials
  • endogenous testosterone
  • strict exclusion
  • research participants

  • developing prostate
  • therapeutic intervention
  • trials recommended
  • potential adverse
  • sexual function

  • initial trials
  • benign prostatic
  • committee determined
  • ethical considerations
  • prostatic hyperplasia

  • effective therapeutic
  • cognitive dysfunction
  • rational option
  • adequate scientific
  • empirical evidence

  • widely prescribing
  • following clinical
  • adequate benefits
  • human research
  • normal testosterone


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