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J Gerontol A Biol Sci Med Sci. 2015 Sep;70(9):1105-11. doi: 10.1093/gerona/glv031. Epub 2015 Apr 15.

Recruitment and Screening for the Testosterone Trials.

Author information

1
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh. jcauley@edc.pitt.edu.
2
Center for Clinical Epidemiology & Biostatistics, and.
3
Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
4
Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.
5
Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis. Minneapolis VA Health Care System, Minnesota.
6
Division of Epidemiology, Department of Family and Preventative Medicine, University of California, San Diego School of Medicine, La Jolla.
7
Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.
8
Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle.
9
Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
10
Department of Aging & Geriatric Research, University of Florida, Gainesville.
11
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
12
New England Research Institutes, Inc., Watertown, Massachusetts.
13
Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, Maryland.
14
Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance.
15
Division of Preventive Medicine, University of Alabama at Birmingham.
16
Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
17
Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.
18
Section of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Massachusetts.
19
Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis.
20
Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

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

PMID:
25878029
PMCID:
PMC4861649
DOI:
10.1093/gerona/glv031
[Indexed for MEDLINE]
Free PMC Article

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