Adverse events associated with testosterone administration

Adverse events associated with testosterone administration / Shehzad Basaria, Andrea D. Coviello, Thomas G. Travison, Thomas W. Storer, Wildon R. Farwell, Alan M. Jette, Richard Eder, Sharon Tennstedt, Jagadish Ulloor, Anqi Zhang, Karen Choong, Kishore M. Lakshman, Norman A. Mazer, Renee Miciek, Joanne Krasnoff, Ayan Elmi, Philip E. Knapp, Brad Brooks, Erica Appleman, Sheetal Aggarwal, Geeta Bhasin, Leif Hede-Brierley, Ashmeet Bhatia, Lauren Collins, Nathan LeBrasseur, Louis D. Fiore, Shalender Bhasin. - (New England Journal of Medicine 363 (2010) 2 (8 July); p. 109-122)

  • PMID: 20592293
  • PMCID: PMC3440621
  • DOI: 10.1056/NEJMoa1000485


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.

Original document


Research / Study
8 July 2010
Aggarwal, Sheetal
Appleman, Erica
Basaria, Shehzad
Bhasin, Geeta
Bhasin, Shalender
Bhatia, Ashmeet
Brooks, Brad
Choong, Karen
Collins, Lauren
Coviello, Andrea D.
Eder, Richard
Elmi, Ayan
Farwell, Wildon R.
Fiore, Louis D.
Hede-Brierley, Leif
Jette, Alan M.
Knapp, Philip E.
Krasnoff, Joanne
Lakshman, Kishore M.
LeBrasseur, Nathan
Mazer, Norman A.
Miciek, Renee
Storer, Thomas W.
Tennstedt, Sharon
Travison, Thomas G.
Ulloor, Jagadish
Zhang, Anqi
United States of America
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Boston University School of Medicine (BUSM)
Boston University School of Public Health (BUSPH)
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S1. Anabolic Agents
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Cardiovascular diseases
Health effects
Legitimate Medical Treatment
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Scientific article
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Date generated
1 July 2021
Date of last modification
15 July 2021
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