title: Recruitment and Screening for the Testosterone Trials.
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).
  
  
  CONCLUSIONS
  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.
authors: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh. jcauley@edc.pitt.edu.
authors: Jane A
authors: JA
authors: Cauley
authors: Center for Clinical Epidemiology & Biostatistics, and.
authors: Laura
authors: L
authors: Fluharty
authors: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors: Susan S
authors: SS
authors: Ellenberg
authors: Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.
authors: Thomas M
authors: TM
authors: Gill
authors: Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis. Minneapolis VA Health Care System, Minnesota.
authors: Kristine E
authors: KE
authors: Ensrud
authors: Division of Epidemiology, Department of Family and Preventative Medicine, University of California, San Diego School of Medicine, La Jolla.
authors: Elizabeth
authors: E
authors: Barrett-Connor
authors: Center for Clinical Epidemiology & Biostatistics, and.
authors: Denise
authors: D
authors: Cifelli
authors: Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.
authors: Glenn R
authors: GR
authors: Cunningham
authors: 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.
authors: Alvin M
authors: AM
authors: Matsumoto
authors: Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors: Shalender
authors: S
authors: Bhasin
authors: Department of Aging & Geriatric Research, University of Florida, Gainesville.
authors: Marco
authors: M
authors: Pahor
authors: Division of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.
authors: John T
authors: JT
authors: Farrar
authors: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors: David
authors: D
authors: Cella
authors: New England Research Institutes, Inc., Watertown, Massachusetts.
authors: Raymond C
authors: RC
authors: Rosen
authors: Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, Maryland.
authors: Susan M
authors: SM
authors: Resnick
authors: Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance.
authors: Ronald S
authors: RS
authors: Swerdloff
authors: Division of Preventive Medicine, University of Alabama at Birmingham.
authors: Cora E
authors: CE
authors: Lewis
authors: Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
authors: Mark E
authors: ME
authors: Molitch
authors: Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.
authors: Jill P
authors: JP
authors: Crandall
authors: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors: Alisa J
authors: AJ
authors: Stephens-Shields
authors: Section of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Massachusetts.
authors: Thomas W
authors: TW
authors: Strorer
authors: Division of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance.
authors: Christina
authors: C
authors: Wang
authors: Department of Aging & Geriatric Research, University of Florida, Gainesville.
authors: Stephen
authors: S
authors: Anton
authors: Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors: Shehzad
authors: S
authors: Basaria
authors: Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis.
authors: Susan
authors: S
authors: Diem
authors: Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.
authors: Vafa
authors: V
authors: Tabatabaie
authors: Center for Clinical Epidemiology & Biostatistics, and.
authors: Darlene
authors: D
authors: Dougar
authors: Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors: Xiaoling
authors: X
authors: Hou
authors: Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
authors: Peter J
authors: PJ
authors: Snyder
mesh_terms: D000368:Aged; D006801:Humans; D007407:Interviews as Topic; D007989:Libido; D008297:Male; D051346:Mobility Limitation; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013739:Testosterone / Q000097:blood
chemical_list: D013739:Testosterone
keywords: Hypogonadal men; Physical function; Randomized clinical trials.; Recruitment; Sexual function; Testosterone treatment; Vitality