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. 2015 Sep;70(9):1105-11.
doi: 10.1093/gerona/glv031. Epub 2015 Apr 15.

Recruitment and Screening for the Testosterone Trials

Jane A Cauley  1 , Laura Fluharty  2 , Susan S Ellenberg  3 , Thomas M Gill  4 , Kristine E Ensrud  5 , Elizabeth Barrett-Connor  6 , Denise Cifelli  2 , Glenn R Cunningham  7 , Alvin M Matsumoto  8 , Shalender Bhasin  9 , Marco Pahor  10 , John T Farrar  4 , David Cella  11 , Raymond C Rosen  12 , Susan M Resnick  13 , Ronald S Swerdloff  14 , Cora E Lewis  15 , Mark E Molitch  16 , Jill P Crandall  17 , Alisa J Stephens-Shields  3 , Thomas W Strorer  18 , Christina Wang  14 , Stephen Anton  10 , Shehzad Basaria  9 , Susan Diem  19 , Vafa Tabatabaie  17 , Darlene Dougar  2 , Xiaoling Hou  3 , Peter J Snyder  20
Affiliations

Recruitment and Screening for the Testosterone Trials

Jane A Cauley et al. J Gerontol A Biol Sci Med Sci. 2015 Sep.

Abstract

Background: We describe the recruitment of men for The Testosterone (T) Trials, which were designed to determine the efficacy of T treatment.

Methods: Men were eligible if they were ≥65 years, had an average of two morning total T values <275 ng/dL with neither value >300 ng/mL, and had symptoms and objective evidence of mobility limitation, sexual dysfunction, and/or low vitality. Men had to be eligible for and enroll in at least one of these three main trials (physical function, sexual function, vitality).

Results: Men were recruited primarily through mass mailings in 12 U.S. communities: 82% of men who contacted the sites did so in response to mailings. Men who responded were screened by telephone to ascertain eligibility. Of 51,085 telephone screens, 53.5% were eligible for further screening. Of 23,889 initial screening visits (SV1), 2,781 (11.6%) men were eligible for the second screening visit (SV2), which 2,261 (81.3%) completed. At SV2, 931 (41.2%) men met the criteria for one or more trials, the T level criterion and had no other exclusions. Of these, 790 (84.6%) were randomized; 99 (12.5%) in all three trials and 348 (44%) in two trials. Their mean age was 72 years and mean body mass index (BMI) was 31.0 kg/m(2). Mean (standard deviation) total T (ng/dL) was 212.0 (40.0).

Conclusion: Despite the telephone screening to enrollment ratio of 65 to 1, we met the recruitment goals for each trial. Recruitment of symptomatic older men with low testosterone levels is difficult but feasible.

Keywords: Hypogonadal men; Physical function; Randomized clinical trials.; Recruitment; Sexual function; Testosterone treatment; Vitality.

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Figures

Figure 1.
Figure 1.
Testosterone trials screening to recruitment funnel. Percentages calculated as percent of total number of telephone screens. IPPS = International Prostate Symptom Score; DRE = digital rectal exam.
Figure 2
Figure 2
Venn diagram showing overlap in the enrollment of men into the main testosterone trials: physical function, sexual function, and vitality.
See this image and copyright information in PMC

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