Cited by 1,494Hormonal and reproductive studiesMenopause: Health Impacts and TreatmentsAdrenal Hormones and Disorders

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Adverse Events Associated with Testosterone Administration

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Abstract

BACKGROUND: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. METHODS: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. RESULTS: A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. CONCLUSIONS: In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)

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Metadata

Authors
Basaria, S., Coviello, A. D., Travison, T. G., Storer, T. W., Farwell, W. R., Jette, A. M., Eder, R., Tennstedt, S., Ulloor, J., Zhang, A., Choong, K., Lakshman, K. M., Mazer, N. A., Miciek, R., Krasnoff, J., Elmi, A., Knapp, P. E., Brooks, B., Appleman, E., Aggarwal, S., Bhasin, G., Hede-Brierley, L., Bhatia, A., Collins, L., LeBrasseur, N., Fiore, L. D., & Bhasin, S.
Affiliations
  • Boston University (US)
  • Brigham and Women's Hospital (US)
  • New England Research Institutes (US)
Venue
New England Journal of Medicine
Published
2010-07-08
Volume
363
Issue
2
Pages
109-122
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2155877918
Cited by
1,494
References
56
Citations by year
2026: 33 · 2025: 52 · 2024: 68 · 2023: 63 · 2022: 76 · 2021: 66 · 2020: 91 · 2019: 65 · 2018: 92 · 2017: 132 · 2016: 103 · 2015: 122 · 2014: 169 · 2013: 96 · 2012: 108
FWCI
85.68
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • U.S. Department of Veterans Affairs
  • National Institutes of Health (5p30ag031679-15)
  • National Institute on Aging (U01AG014369, R01AG037193, 5 P30 AG031679, P30-AG031679, 1UO1AG14369)
  • National Center for Research Resources (UL1RR025771)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords
testosterone replacement therapy, testosterone gel, adverse events, cardiovascular events, older men, mobility limitations, hypogonadism, muscle strength, trial discontinuation, drug safety
MeSH terms
Administration, Cutaneous, Aged, Aged, 80 and over, Cardiovascular Diseases, Double-Blind Method, Exercise Test, Gels, Humans, Hyperlipidemias, Hypertension, Male, Obesity, Risk Factors, Testosterone, Logistic Models, Walking, Kaplan-Meier Estimate, Muscle Strength

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