THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN
Identifieur interne : 001066 ( Pmc/Corpus ); précédent : 001065; suivant : 001067THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN
Auteurs : Peter J. Snyder ; Susan S. Ellenberg ; Glenn R. Cunningham ; Alvin M. Matsumoto ; Shalender Bhasin ; Elizabeth Barrett-Connor ; Thomas M. Gill ; John T. Farrar ; David Cella ; Raymond C. Rosen ; Susan M. Resnick ; Ronald S. Swerdloff ; Jane A. Cauley ; Denise Cifelli ; Laura Fluharty ; Marco Pahor ; Kristine E. Ensrud ; Cora E. Lewis ; Mark E. Molitch ; Jill P. Crandall ; Christina Wang ; Matthew J. Budoff ; Nanette K. Wenger ; Emile R. Mohler ; Diane E. Bild ; Nakela L. Cook ; Tony M. Keaveny ; David L. Kopperdahl ; David Lee ; Ann V. Schwartz ; Thomas W. Storer ; William B. Ershler ; Cindy N. Roy ; Leslie J. Raffel ; Sergei Romashkan ; Evan HadleySource :
- Clinical trials (London, England) [ 1740-7745 ] ; 2014.
Abstract
The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results.
To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and determine definitively if testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions.
We present the scientific and clinical rationale for the decisions made in the design of this trial.
We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and also symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, treatment and monitoring and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data safety monitoring board (DSMB), the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in subject selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary end points for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation.
Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one subject.
The Testosterone Trials were designed to determine definitively if testosterone treatment of elderly men with low testosterone would have any clinical benefit. Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort.
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DOI: 10.1177/1740774514524032
PubMed: 24686158
PubMed Central: 4182174
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN</title><author><name sortKey="Snyder, Peter J" sort="Snyder, Peter J" uniqKey="Snyder P" first="Peter J" last="Snyder">Peter J. Snyder</name><affiliation><nlm:aff id="A1">Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Ellenberg, Susan S" sort="Ellenberg, Susan S" uniqKey="Ellenberg S" first="Susan S" last="Ellenberg">Susan S. Ellenberg</name><affiliation><nlm:aff id="A2">Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cunningham, Glenn R" sort="Cunningham, Glenn R" uniqKey="Cunningham G" first="Glenn R" last="Cunningham">Glenn R. Cunningham</name><affiliation><nlm:aff id="A3">Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and St. Luke's Episcopal Hospital, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Matsumoto, Alvin M" sort="Matsumoto, Alvin M" uniqKey="Matsumoto A" first="Alvin M" last="Matsumoto">Alvin M. Matsumoto</name><affiliation><nlm:aff id="A4">Geriatric Research, Education, and Clinical Center, Division of Gerontology & Geriatric Medicine, Department of Veterans Affairs Puget Sound Health Care System, Department of Internal Medicine, University of Washington School of Medicine, Seattle, WA, USA</nlm:aff></affiliation></author><author><name sortKey="Bhasin, Shalender" sort="Bhasin, Shalender" uniqKey="Bhasin S" first="Shalender" last="Bhasin">Shalender Bhasin</name><affiliation><nlm:aff id="A5">Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Barrett Connor, Elizabeth" sort="Barrett Connor, Elizabeth" uniqKey="Barrett Connor E" first="Elizabeth" last="Barrett-Connor">Elizabeth Barrett-Connor</name><affiliation><nlm:aff id="A6">Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Gill, Thomas M" sort="Gill, Thomas M" uniqKey="Gill T" first="Thomas M" last="Gill">Thomas M. Gill</name><affiliation><nlm:aff id="A7">Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT, USA</nlm:aff></affiliation></author><author><name sortKey="Farrar, John T" sort="Farrar, John T" uniqKey="Farrar J" first="John T" last="Farrar">John T. Farrar</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cella, David" sort="Cella, David" uniqKey="Cella D" first="David" last="Cella">David Cella</name><affiliation><nlm:aff id="A9">Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA</nlm:aff></affiliation></author><author><name sortKey="Rosen, Raymond C" sort="Rosen, Raymond C" uniqKey="Rosen R" first="Raymond C" last="Rosen">Raymond C. Rosen</name><affiliation><nlm:aff id="A10">New England Research Institutes, Watertown, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Resnick, Susan M" sort="Resnick, Susan M" uniqKey="Resnick S" first="Susan M" last="Resnick">Susan M. Resnick</name><affiliation><nlm:aff id="A11">Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Swerdloff, Ronald S" sort="Swerdloff, Ronald S" uniqKey="Swerdloff R" first="Ronald S" last="Swerdloff">Ronald S. Swerdloff</name><affiliation><nlm:aff id="A12">Division of Endocrinology , Harbor-University of California at Los Angeles Medical Center; Los Angeles Biomedical Research Institute ;Torrance, CA; David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Cauley, Jane A" sort="Cauley, Jane A" uniqKey="Cauley J" first="Jane A" last="Cauley">Jane A. Cauley</name><affiliation><nlm:aff id="A13">Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cifelli, Denise" sort="Cifelli, Denise" uniqKey="Cifelli D" first="Denise" last="Cifelli">Denise Cifelli</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Fluharty, Laura" sort="Fluharty, Laura" uniqKey="Fluharty L" first="Laura" last="Fluharty">Laura Fluharty</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Pahor, Marco" sort="Pahor, Marco" uniqKey="Pahor M" first="Marco" last="Pahor">Marco Pahor</name><affiliation><nlm:aff id="A14">Department of Aging & Geriatric Research, University of Florida, Gainesville, FL, USA</nlm:aff></affiliation></author><author><name sortKey="Ensrud, Kristine E" sort="Ensrud, Kristine E" uniqKey="Ensrud K" first="Kristine E" last="Ensrud">Kristine E. Ensrud</name><affiliation><nlm:aff id="A15">Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA</nlm:aff></affiliation></author><author><name sortKey="Lewis, Cora E" sort="Lewis, Cora E" uniqKey="Lewis C" first="Cora E" last="Lewis">Cora E. Lewis</name><affiliation><nlm:aff id="A16">Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA</nlm:aff></affiliation></author><author><name sortKey="Molitch, Mark E" sort="Molitch, Mark E" uniqKey="Molitch M" first="Mark E" last="Molitch">Mark E. Molitch</name><affiliation><nlm:aff id="A17">Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA</nlm:aff></affiliation></author><author><name sortKey="Crandall, Jill P" sort="Crandall, Jill P" uniqKey="Crandall J" first="Jill P" last="Crandall">Jill P. Crandall</name><affiliation><nlm:aff id="A18">Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Wang, Christina" sort="Wang, Christina" uniqKey="Wang C" first="Christina" last="Wang">Christina Wang</name><affiliation><nlm:aff id="A12">Division of Endocrinology , Harbor-University of California at Los Angeles Medical Center; Los Angeles Biomedical Research Institute ;Torrance, CA; David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Budoff, Matthew J" sort="Budoff, Matthew J" uniqKey="Budoff M" first="Matthew J" last="Budoff">Matthew J. Budoff</name><affiliation><nlm:aff id="A19">Division of Cardiology, Los Angeles Biomedical Research Institute, Harbor-University of California at Los Angeles Medical Center, Torrance, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Wenger, Nanette K" sort="Wenger, Nanette K" uniqKey="Wenger N" first="Nanette K" last="Wenger">Nanette K. Wenger</name><affiliation><nlm:aff id="A20">Division of Cardiology, Emory Heart and Vascular Center, Emory University School of Medicine, Atlanta, GA, USA</nlm:aff></affiliation></author><author><name sortKey="Mohler, Emile R" sort="Mohler, Emile R" uniqKey="Mohler E" first="Emile R" last="Mohler">Emile R. Mohler</name><affiliation><nlm:aff id="A21">Division of Cardiovascular Disease and Section of Vascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Bild, Diane E" sort="Bild, Diane E" uniqKey="Bild D" first="Diane E" last="Bild">Diane E. Bild</name><affiliation><nlm:aff id="A22">Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Cook, Nakela L" sort="Cook, Nakela L" uniqKey="Cook N" first="Nakela L" last="Cook">Nakela L. Cook</name><affiliation><nlm:aff id="A23">Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, Centers for Cardiovascular Outcomes Research, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Keaveny, Tony M" sort="Keaveny, Tony M" uniqKey="Keaveny T" first="Tony M" last="Keaveny">Tony M. Keaveny</name><affiliation><nlm:aff id="A24">Departments of Mechanical Engineering and Bioengineering, University of California and ON Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Kopperdahl, David L" sort="Kopperdahl, David L" uniqKey="Kopperdahl D" first="David L" last="Kopperdahl">David L. Kopperdahl</name><affiliation><nlm:aff id="A25">O.N. Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Lee, David" sort="Lee, David" uniqKey="Lee D" first="David" last="Lee">David Lee</name><affiliation><nlm:aff id="A25">O.N. Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Schwartz, Ann V" sort="Schwartz, Ann V" uniqKey="Schwartz A" first="Ann V" last="Schwartz">Ann V. Schwartz</name><affiliation><nlm:aff id="A26">Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Storer, Thomas W" sort="Storer, Thomas W" uniqKey="Storer T" first="Thomas W" last="Storer">Thomas W. Storer</name><affiliation><nlm:aff id="A27">Section of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Ershler, William B" sort="Ershler, William B" uniqKey="Ershler W" first="William B" last="Ershler">William B. Ershler</name><affiliation><nlm:aff id="A28">Division of Hematology/Oncology, Institute for Advanced Studies in Aging, Falls Church, VA, USA</nlm:aff></affiliation></author><author><name sortKey="Roy, Cindy N" sort="Roy, Cindy N" uniqKey="Roy C" first="Cindy N" last="Roy">Cindy N. Roy</name><affiliation><nlm:aff id="A29">Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Raffel, Leslie J" sort="Raffel, Leslie J" uniqKey="Raffel L" first="Leslie J" last="Raffel">Leslie J. Raffel</name><affiliation><nlm:aff id="A30">Medical Genetics Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Romashkan, Sergei" sort="Romashkan, Sergei" uniqKey="Romashkan S" first="Sergei" last="Romashkan">Sergei Romashkan</name><affiliation><nlm:aff id="A31">Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Hadley, Evan" sort="Hadley, Evan" uniqKey="Hadley E" first="Evan" last="Hadley">Evan Hadley</name><affiliation><nlm:aff id="A31">Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD, USA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24686158</idno><idno type="pmc">4182174</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4182174</idno><idno type="RBID">PMC:4182174</idno><idno type="doi">10.1177/1740774514524032</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001066</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001066</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN</title><author><name sortKey="Snyder, Peter J" sort="Snyder, Peter J" uniqKey="Snyder P" first="Peter J" last="Snyder">Peter J. Snyder</name><affiliation><nlm:aff id="A1">Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Ellenberg, Susan S" sort="Ellenberg, Susan S" uniqKey="Ellenberg S" first="Susan S" last="Ellenberg">Susan S. Ellenberg</name><affiliation><nlm:aff id="A2">Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cunningham, Glenn R" sort="Cunningham, Glenn R" uniqKey="Cunningham G" first="Glenn R" last="Cunningham">Glenn R. Cunningham</name><affiliation><nlm:aff id="A3">Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and St. Luke's Episcopal Hospital, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Matsumoto, Alvin M" sort="Matsumoto, Alvin M" uniqKey="Matsumoto A" first="Alvin M" last="Matsumoto">Alvin M. Matsumoto</name><affiliation><nlm:aff id="A4">Geriatric Research, Education, and Clinical Center, Division of Gerontology & Geriatric Medicine, Department of Veterans Affairs Puget Sound Health Care System, Department of Internal Medicine, University of Washington School of Medicine, Seattle, WA, USA</nlm:aff></affiliation></author><author><name sortKey="Bhasin, Shalender" sort="Bhasin, Shalender" uniqKey="Bhasin S" first="Shalender" last="Bhasin">Shalender Bhasin</name><affiliation><nlm:aff id="A5">Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Barrett Connor, Elizabeth" sort="Barrett Connor, Elizabeth" uniqKey="Barrett Connor E" first="Elizabeth" last="Barrett-Connor">Elizabeth Barrett-Connor</name><affiliation><nlm:aff id="A6">Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Gill, Thomas M" sort="Gill, Thomas M" uniqKey="Gill T" first="Thomas M" last="Gill">Thomas M. Gill</name><affiliation><nlm:aff id="A7">Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT, USA</nlm:aff></affiliation></author><author><name sortKey="Farrar, John T" sort="Farrar, John T" uniqKey="Farrar J" first="John T" last="Farrar">John T. Farrar</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cella, David" sort="Cella, David" uniqKey="Cella D" first="David" last="Cella">David Cella</name><affiliation><nlm:aff id="A9">Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA</nlm:aff></affiliation></author><author><name sortKey="Rosen, Raymond C" sort="Rosen, Raymond C" uniqKey="Rosen R" first="Raymond C" last="Rosen">Raymond C. Rosen</name><affiliation><nlm:aff id="A10">New England Research Institutes, Watertown, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Resnick, Susan M" sort="Resnick, Susan M" uniqKey="Resnick S" first="Susan M" last="Resnick">Susan M. Resnick</name><affiliation><nlm:aff id="A11">Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Swerdloff, Ronald S" sort="Swerdloff, Ronald S" uniqKey="Swerdloff R" first="Ronald S" last="Swerdloff">Ronald S. Swerdloff</name><affiliation><nlm:aff id="A12">Division of Endocrinology , Harbor-University of California at Los Angeles Medical Center; Los Angeles Biomedical Research Institute ;Torrance, CA; David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Cauley, Jane A" sort="Cauley, Jane A" uniqKey="Cauley J" first="Jane A" last="Cauley">Jane A. Cauley</name><affiliation><nlm:aff id="A13">Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Cifelli, Denise" sort="Cifelli, Denise" uniqKey="Cifelli D" first="Denise" last="Cifelli">Denise Cifelli</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Fluharty, Laura" sort="Fluharty, Laura" uniqKey="Fluharty L" first="Laura" last="Fluharty">Laura Fluharty</name><affiliation><nlm:aff id="A8">Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Pahor, Marco" sort="Pahor, Marco" uniqKey="Pahor M" first="Marco" last="Pahor">Marco Pahor</name><affiliation><nlm:aff id="A14">Department of Aging & Geriatric Research, University of Florida, Gainesville, FL, USA</nlm:aff></affiliation></author><author><name sortKey="Ensrud, Kristine E" sort="Ensrud, Kristine E" uniqKey="Ensrud K" first="Kristine E" last="Ensrud">Kristine E. Ensrud</name><affiliation><nlm:aff id="A15">Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA</nlm:aff></affiliation></author><author><name sortKey="Lewis, Cora E" sort="Lewis, Cora E" uniqKey="Lewis C" first="Cora E" last="Lewis">Cora E. Lewis</name><affiliation><nlm:aff id="A16">Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA</nlm:aff></affiliation></author><author><name sortKey="Molitch, Mark E" sort="Molitch, Mark E" uniqKey="Molitch M" first="Mark E" last="Molitch">Mark E. Molitch</name><affiliation><nlm:aff id="A17">Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA</nlm:aff></affiliation></author><author><name sortKey="Crandall, Jill P" sort="Crandall, Jill P" uniqKey="Crandall J" first="Jill P" last="Crandall">Jill P. Crandall</name><affiliation><nlm:aff id="A18">Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Wang, Christina" sort="Wang, Christina" uniqKey="Wang C" first="Christina" last="Wang">Christina Wang</name><affiliation><nlm:aff id="A12">Division of Endocrinology , Harbor-University of California at Los Angeles Medical Center; Los Angeles Biomedical Research Institute ;Torrance, CA; David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Budoff, Matthew J" sort="Budoff, Matthew J" uniqKey="Budoff M" first="Matthew J" last="Budoff">Matthew J. Budoff</name><affiliation><nlm:aff id="A19">Division of Cardiology, Los Angeles Biomedical Research Institute, Harbor-University of California at Los Angeles Medical Center, Torrance, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Wenger, Nanette K" sort="Wenger, Nanette K" uniqKey="Wenger N" first="Nanette K" last="Wenger">Nanette K. Wenger</name><affiliation><nlm:aff id="A20">Division of Cardiology, Emory Heart and Vascular Center, Emory University School of Medicine, Atlanta, GA, USA</nlm:aff></affiliation></author><author><name sortKey="Mohler, Emile R" sort="Mohler, Emile R" uniqKey="Mohler E" first="Emile R" last="Mohler">Emile R. Mohler</name><affiliation><nlm:aff id="A21">Division of Cardiovascular Disease and Section of Vascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Bild, Diane E" sort="Bild, Diane E" uniqKey="Bild D" first="Diane E" last="Bild">Diane E. Bild</name><affiliation><nlm:aff id="A22">Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Cook, Nakela L" sort="Cook, Nakela L" uniqKey="Cook N" first="Nakela L" last="Cook">Nakela L. Cook</name><affiliation><nlm:aff id="A23">Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, Centers for Cardiovascular Outcomes Research, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Keaveny, Tony M" sort="Keaveny, Tony M" uniqKey="Keaveny T" first="Tony M" last="Keaveny">Tony M. Keaveny</name><affiliation><nlm:aff id="A24">Departments of Mechanical Engineering and Bioengineering, University of California and ON Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Kopperdahl, David L" sort="Kopperdahl, David L" uniqKey="Kopperdahl D" first="David L" last="Kopperdahl">David L. Kopperdahl</name><affiliation><nlm:aff id="A25">O.N. Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Lee, David" sort="Lee, David" uniqKey="Lee D" first="David" last="Lee">David Lee</name><affiliation><nlm:aff id="A25">O.N. Diagnostics, Berkeley, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Schwartz, Ann V" sort="Schwartz, Ann V" uniqKey="Schwartz A" first="Ann V" last="Schwartz">Ann V. Schwartz</name><affiliation><nlm:aff id="A26">Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Storer, Thomas W" sort="Storer, Thomas W" uniqKey="Storer T" first="Thomas W" last="Storer">Thomas W. Storer</name><affiliation><nlm:aff id="A27">Section of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Ershler, William B" sort="Ershler, William B" uniqKey="Ershler W" first="William B" last="Ershler">William B. Ershler</name><affiliation><nlm:aff id="A28">Division of Hematology/Oncology, Institute for Advanced Studies in Aging, Falls Church, VA, USA</nlm:aff></affiliation></author><author><name sortKey="Roy, Cindy N" sort="Roy, Cindy N" uniqKey="Roy C" first="Cindy N" last="Roy">Cindy N. Roy</name><affiliation><nlm:aff id="A29">Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Raffel, Leslie J" sort="Raffel, Leslie J" uniqKey="Raffel L" first="Leslie J" last="Raffel">Leslie J. Raffel</name><affiliation><nlm:aff id="A30">Medical Genetics Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Romashkan, Sergei" sort="Romashkan, Sergei" uniqKey="Romashkan S" first="Sergei" last="Romashkan">Sergei Romashkan</name><affiliation><nlm:aff id="A31">Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD, USA</nlm:aff></affiliation></author><author><name sortKey="Hadley, Evan" sort="Hadley, Evan" uniqKey="Hadley E" first="Evan" last="Hadley">Evan Hadley</name><affiliation><nlm:aff id="A31">Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD, USA</nlm:aff></affiliation></author></analytic><series><title level="j">Clinical trials (London, England)</title><idno type="ISSN">1740-7745</idno><idno type="eISSN">1740-7753</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results.</p></sec><sec id="S2"><title>Purpose</title><p id="P2">To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and determine definitively if testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions.</p></sec><sec id="S3"><title>Methods</title><p id="P3">We present the scientific and clinical rationale for the decisions made in the design of this trial.</p></sec><sec id="S4"><title>Results</title><p id="P4">We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and also symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, treatment and monitoring and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data safety monitoring board (DSMB), the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in subject selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary end points for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation.</p></sec><sec id="S5"><title>Potential Limitations</title><p id="P5">Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one subject.</p></sec><sec id="S6"><title>Conclusions</title><p id="P6">The Testosterone Trials were designed to determine definitively if testosterone treatment of elderly men with low testosterone would have any clinical benefit. Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101197451</journal-id><journal-id journal-id-type="pubmed-jr-id">32521</journal-id><journal-id journal-id-type="nlm-ta">Clin Trials</journal-id><journal-id journal-id-type="iso-abbrev">Clin Trials</journal-id><journal-title-group><journal-title>Clinical trials (London, England)</journal-title></journal-title-group><issn pub-type="ppub">1740-7745</issn><issn pub-type="epub">1740-7753</issn></journal-meta><article-meta><article-id pub-id-type="pmid">24686158</article-id><article-id pub-id-type="pmc">4182174</article-id><article-id pub-id-type="doi">10.1177/1740774514524032</article-id><article-id pub-id-type="manuscript">NIHMS612630</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Snyder</surname><given-names>Peter J</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A1">1</xref></contrib><contrib contrib-type="author"><name><surname>Ellenberg</surname><given-names>Susan S</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A2">2</xref></contrib><contrib contrib-type="author"><name><surname>Cunningham</surname><given-names>Glenn R</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A3">3</xref></contrib><contrib contrib-type="author"><name><surname>Matsumoto</surname><given-names>Alvin M</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A4">4</xref></contrib><contrib contrib-type="author"><name><surname>Bhasin</surname><given-names>Shalender</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A5">5</xref></contrib><contrib contrib-type="author"><name><surname>Barrett-Connor</surname><given-names>Elizabeth</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A6">6</xref></contrib><contrib contrib-type="author"><name><surname>Gill</surname><given-names>Thomas M</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A7">7</xref></contrib><contrib contrib-type="author"><name><surname>Farrar</surname><given-names>John T</given-names></name><degrees>MD PhD</degrees><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Cella</surname><given-names>David</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A9">9</xref></contrib><contrib contrib-type="author"><name><surname>Rosen</surname><given-names>Raymond C</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A10">10</xref></contrib><contrib contrib-type="author"><name><surname>Resnick</surname><given-names>Susan M</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A11">11</xref></contrib><contrib contrib-type="author"><name><surname>Swerdloff</surname><given-names>Ronald S</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>Cauley</surname><given-names>Jane A</given-names><prefix>Dr</prefix></name><degrees>PH</degrees><xref ref-type="aff" rid="A13">13</xref></contrib><contrib contrib-type="author"><name><surname>Cifelli</surname><given-names>Denise</given-names></name><degrees>MS</degrees><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Fluharty</surname><given-names>Laura</given-names></name><degrees>MPH</degrees><xref ref-type="aff" rid="A8">8</xref></contrib><contrib contrib-type="author"><name><surname>Pahor</surname><given-names>Marco</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A14">14</xref></contrib><contrib contrib-type="author"><name><surname>Ensrud</surname><given-names>Kristine E</given-names></name><degrees>MD MPH</degrees><xref ref-type="aff" rid="A15">15</xref></contrib><contrib contrib-type="author"><name><surname>Lewis</surname><given-names>Cora E</given-names></name><degrees>MD MPH</degrees><xref ref-type="aff" rid="A16">16</xref></contrib><contrib contrib-type="author"><name><surname>Molitch</surname><given-names>Mark E</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A17">17</xref></contrib><contrib contrib-type="author"><name><surname>Crandall</surname><given-names>Jill P</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A18">18</xref></contrib><contrib contrib-type="author"><name><surname>Wang</surname><given-names>Christina</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A12">12</xref></contrib><contrib contrib-type="author"><name><surname>Budoff</surname><given-names>Matthew J</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A19">19</xref></contrib><contrib contrib-type="author"><name><surname>Wenger</surname><given-names>Nanette K</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A20">20</xref></contrib><contrib contrib-type="author"><name><surname>Mohler</surname><given-names>Emile R</given-names><suffix>3rd</suffix></name><degrees>MD</degrees><xref ref-type="aff" rid="A21">21</xref></contrib><contrib contrib-type="author"><name><surname>Bild</surname><given-names>Diane E</given-names></name><degrees>MD MPH</degrees><xref ref-type="aff" rid="A22">22</xref></contrib><contrib contrib-type="author"><name><surname>Cook</surname><given-names>Nakela L</given-names></name><degrees>MD MPH</degrees><xref ref-type="aff" rid="A23">23</xref></contrib><contrib contrib-type="author"><name><surname>Keaveny</surname><given-names>Tony M</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A24">24</xref></contrib><contrib contrib-type="author"><name><surname>Kopperdahl</surname><given-names>David L</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A25">25</xref></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>David</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A25">25</xref></contrib><contrib contrib-type="author"><name><surname>Schwartz</surname><given-names>Ann V</given-names></name><degrees>PhD MPH</degrees><xref ref-type="aff" rid="A26">26</xref></contrib><contrib contrib-type="author"><name><surname>Storer</surname><given-names>Thomas W</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A27">27</xref></contrib><contrib contrib-type="author"><name><surname>Ershler</surname><given-names>William B</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A28">28</xref></contrib><contrib contrib-type="author"><name><surname>Roy</surname><given-names>Cindy N</given-names></name><degrees>PhD</degrees><xref ref-type="aff" rid="A29">29</xref></contrib><contrib contrib-type="author"><name><surname>Raffel</surname><given-names>Leslie J</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A30">30</xref></contrib><contrib contrib-type="author"><name><surname>Romashkan</surname><given-names>Sergei</given-names></name><degrees>MD PhD</degrees><xref ref-type="aff" rid="A31">31</xref></contrib><contrib contrib-type="author"><name><surname>Hadley</surname><given-names>Evan</given-names></name><degrees>MD</degrees><xref ref-type="aff" rid="A31">31</xref></contrib></contrib-group><aff id="A1"><label>1</label>Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="A2"><label>2</label>Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="A3"><label>3</label>Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and St. Luke's Episcopal Hospital, Houston, TX, USA</aff><aff id="A4"><label>4</label>Geriatric Research, Education, and Clinical Center, Division of Gerontology & Geriatric Medicine, Department of Veterans Affairs Puget Sound Health Care System, Department of Internal Medicine, University of Washington School of Medicine, Seattle, WA, USA</aff><aff id="A5"><label>5</label>Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA</aff><aff id="A6"><label>6</label>Department of Family and Preventative Medicine, University of California San Diego School of Medicine, La Jolla, CA, USA</aff><aff id="A7"><label>7</label>Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT, USA</aff><aff id="A8"><label>8</label>Center for Clinical Epidemiology & Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="A9"><label>9</label>Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA</aff><aff id="A10"><label>10</label>New England Research Institutes, Watertown, MA, USA</aff><aff id="A11"><label>11</label>Laboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA</aff><aff id="A12"><label>12</label>Division of Endocrinology , Harbor-University of California at Los Angeles Medical Center; Los Angeles Biomedical Research Institute ;Torrance, CA; David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA</aff><aff id="A13"><label>13</label>Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, PA, USA</aff><aff id="A14"><label>14</label>Department of Aging & Geriatric Research, University of Florida, Gainesville, FL, USA</aff><aff id="A15"><label>15</label>Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, MN, USA</aff><aff id="A16"><label>16</label>Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA</aff><aff id="A17"><label>17</label>Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA</aff><aff id="A18"><label>18</label>Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, NY, USA</aff><aff id="A19"><label>19</label>Division of Cardiology, Los Angeles Biomedical Research Institute, Harbor-University of California at Los Angeles Medical Center, Torrance, CA, USA</aff><aff id="A20"><label>20</label>Division of Cardiology, Emory Heart and Vascular Center, Emory University School of Medicine, Atlanta, GA, USA</aff><aff id="A21"><label>21</label>Division of Cardiovascular Disease and Section of Vascular Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="A22"><label>22</label>Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</aff><aff id="A23"><label>23</label>Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, Centers for Cardiovascular Outcomes Research, National Heart, Lung, and Blood Institute, Bethesda, MD, USA</aff><aff id="A24"><label>24</label>Departments of Mechanical Engineering and Bioengineering, University of California and ON Diagnostics, Berkeley, CA, USA</aff><aff id="A25"><label>25</label>O.N. Diagnostics, Berkeley, CA, USA</aff><aff id="A26"><label>26</label>Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA</aff><aff id="A27"><label>27</label>Section of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Boston, MA, USA</aff><aff id="A28"><label>28</label>Division of Hematology/Oncology, Institute for Advanced Studies in Aging, Falls Church, VA, USA</aff><aff id="A29"><label>29</label>Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA</aff><aff id="A30"><label>30</label>Medical Genetics Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA</aff><aff id="A31"><label>31</label>Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD, USA</aff><author-notes><corresp id="CR1">Corresponding Author: Peter J. Snyder, MD</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>17</day><month>7</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>31</day><month>3</month><year>2014</year></pub-date><pub-date pub-type="ppub"><month>6</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>30</day><month>9</month><year>2015</year></pub-date><volume>11</volume><issue>3</issue><fpage>362</fpage><lpage>375</lpage><pmc-comment>elocation-id from pubmed: 10.1177/1740774514524032</pmc-comment>
<abstract><sec id="S1"><title>Background</title><p id="P1">The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results.</p></sec><sec id="S2"><title>Purpose</title><p id="P2">To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and determine definitively if testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions.</p></sec><sec id="S3"><title>Methods</title><p id="P3">We present the scientific and clinical rationale for the decisions made in the design of this trial.</p></sec><sec id="S4"><title>Results</title><p id="P4">We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and also symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, treatment and monitoring and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data safety monitoring board (DSMB), the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in subject selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary end points for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation.</p></sec><sec id="S5"><title>Potential Limitations</title><p id="P5">Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one subject.</p></sec><sec id="S6"><title>Conclusions</title><p id="P6">The Testosterone Trials were designed to determine definitively if testosterone treatment of elderly men with low testosterone would have any clinical benefit. Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort.</p></sec></abstract><kwd-group><kwd>clinical trial</kwd><kwd>testosterone</kwd><kwd>hypogonadism</kwd><kwd>aging</kwd><kwd>mobility</kwd><kwd>sexual function</kwd><kwd>vitality</kwd><kwd>cognitive function</kwd><kwd>anemia</kwd><kwd>CT angiography</kwd><kwd>volumetric BMD</kwd><kwd>bone strength</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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