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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Recruitment and Screening for the Testosterone Trials.

Jane A Cauley1, Laura Fluharty2, Susan S Ellenberg3

  • 1Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh. jcauley@edc.pitt.edu.

The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences
|April 17, 2015
PubMed
Summary

Recruiting older men with low testosterone for clinical trials is challenging but achievable. Despite a 65:1 screening-to-enrollment ratio, The Testosterone Trials successfully met recruitment goals for testing testosterone treatment efficacy.

Keywords:
Hypogonadal menPhysical functionRandomized clinical trials.RecruitmentSexual functionTestosterone treatmentVitality

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Area of Science:

  • Endocrinology
  • Gerontology
  • Clinical Trials

Background:

  • The Testosterone (T) Trials were designed to evaluate the effectiveness of testosterone replacement therapy.
  • Participant recruitment focused on older men experiencing symptoms potentially related to low testosterone levels.

Purpose of the Study:

  • To describe the recruitment process for The Testosterone (T) Trials.
  • To assess the feasibility of enrolling symptomatic older men with low testosterone levels.

Main Methods:

  • Eligibility criteria included men aged 65+ with low total testosterone (<275 ng/dL), and symptoms of mobility limitation, sexual dysfunction, or low vitality.
  • Recruitment primarily utilized mass mailings, followed by telephone screening and two in-person screening visits.
  • Men had to enroll in at least one of the main trials: physical function, sexual function, or vitality.

Main Results:

  • Mass mailings were the primary recruitment source, with 82% of contacted men responding.
  • A total of 790 men were randomized into the trials after meeting strict eligibility criteria.
  • The mean age of participants was 72 years, with an average total testosterone level of 212.0 ng/dL.

Conclusions:

  • Despite a high screening-to-enrollment ratio (65:1), recruitment goals for The Testosterone Trials were successfully met.
  • Recruiting symptomatic older men with low testosterone levels presents difficulties but is a feasible endeavor.