Study concept and design: Basaria, Harman, Hodis, Storer, Bhasin.
Acquisition, analysis, or interpretation of data: All the authors.
Drafting of the manuscript: Basaria, Harman, Travison, Pencina, Bhasin.
Critical revision of the manuscript for important intellectual content: Basaria, Harman, Hodis, Tsitouras, Budoff, Pencina, Vita, Dzekov, Mazer, Coviello, Knapp, Hally, Pinjic, Yan, Storer, Bhasin.
Statistical analysis: Travison, Pencina.
Obtained funding: Harman, Bhasin.
Administrative, technical, or material support: Hodis, Tsitouras, Budoff, Coviello, Knapp, Hally, Pinjic, Yan, Bhasin.
Study supervision: Basaria, Harman, Hodis, Tsitouras, Budoff, Dzekov, Mazer, Storer, Bhasin.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Basaria reported serving as a consultant to Eli Lily. Dr Bhasin reports receiving grants from Abbvie; research grants outside the submitted work from Regeneron Pharmaceuticals and Eli Lilly, which are administered by the Brigham and Women’s Hospital; personal fees from sanofi, Eli Lilly Co, and Abbvie; having equity interest in Function Promoting Therapies, LLC, outside the submitted work; having a patent application pending for “A Novel Algorithm for Free Testosterone Determination Based on a Novel Model of Testosterone Binding to SHBG,” and a patent application for “The Use of Testosterone Plus Ornithine Decarboxylase Inhibitor as a Prostate Sparing Anabolic Therapy”; serving as the chair of the American Board of Internal Medicine Endocrinology Board Exam Writing Committee; having had served as the chair of the Endocrine Society's expert panel that wrote the clinical guideline for testosterone therapy; receiving personal fees from Eli Lilly and grants from Abbvie Pharmaceuticals outside the submitted work. Dr Mazer reported that he is an employee of Hoffman-LaRoche Co. No other disclosures were reported.
Data and Safety Monitoring Board: Thomas T. Yoshikawa, MD, (chair), Charles R. Drew University; William French, MD, Harbor-UCLA Medical Center; Nand Datta, MD, Charles R. Drew University, none of whom were compensated.
Funding/Support: This investigator-initiated study was supported by a grant from Solvay Pharmaceuticals Inc and later by Abbvie Pharmaceuticals Inc, when Abbvie acquired the Androgel brand from Solvay Pharmaceuticals, and by a grant from the Aurora Foundation to the Kronos Longevity Research Institute. Additional support was provided by grants 5P30AG031679 from the Boston Claude D. Pepper Older Americans Independence Center and 1UL1RR025771 from the Boston University’s Clinical and Translational Science Institute. Testosterone and placebo gel for the study were provided by Solvay Pharmaceuticals Inc and later by Abbvie Pharmaceuticals.
Role of the Funder/Sponsor: Neither the pharmaceutical sponsor nor Aurora had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Information: Database design and maintenance, and data collection were supervised by the Boston University School of Public Health Data Coordinating Center. An independent data and safety monitoring board oversaw the study’s progress and adverse events every 6 months.
Additional Contributions: We thank the staff of Boston University’s CTSI, and John Simon, MD, for overseeing imaging studies in Phoenix. These individuals were not compensated.