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Adverse Events Associated with Testosterone Administration
Open accessAbstract
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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In the citing paper
“Current evidence consistently shows that untreated low testosterone levels are associated with an increased risk of MACE”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [41]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Nevertheless, T supplementation is not without risk and could potentially be harmful concerning cardiovascular risk in the elderly [248].”
From Role of sex hormone-binding globulin in the free hormone hypothesis and the relevance of free testosterone in androgen physiology (2022) · cites this paper as [248]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Several studies have previously reported that testosterone levels are linked to a variety of conditions and diseases, such as cardiovascular disease, type-2 diabetes, the metabolic syndrome, erectile dysfunction, depression, obesity, stroke and osteoporosis. 1-7”
From Cigarette smoking has a positive and independent effect on testosterone levels (2013) · cites this paper as [7]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“studies that measure cardiovascular benefit or harm in men on testosterone therapy have returned inconsistent and controversial results.”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“the current scientific literature does not definitively demonstrate that testosterone therapy increases the risk of MACE.”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [41]
The cited source says what the claim attributes to it.
In the citing paper
“and that testosterone administration can increase the risk of cardiovascular adverse events as well. 7”
From Cigarette smoking has a positive and independent effect on testosterone levels (2013) · cites this paper as [7]
In the citing paper
“Low vitamin D levels have been associated with frailty (133)”
From Frailty in elderly people (2013) · cites this paper as [133]
In the citing paper
“Additionally, testosterone replacement is not without potential risks, including increased respiratory disorders (eg, cough, shortness of breath, asthma or chronic obstructive pulmonary disease (COPD) exacerbation, sleep apnoea) and skin and subcutaneous tissue disorders (eg, application site reactions, itching, erythema, foot ulcers, and increased hair growth).84”
From Age-related and disease-related muscle loss: The effect of diabetes, obesity, and other diseases (2014) · cites this paper as [84]
In the citing paper
“preventing an age-related decline in hormones by exogenous replacement is associated with increased risk for adverse effects in older adults.11-13”
From Hormonal and Metabolic Changes of Aging and the Influence of Lifestyle Modifications (2021) · cites this paper as [13]
In the citing paper
“Unfortunately, hormone replacement therapy is not a panacea, as it often results in various adverse events which outweigh its potential health benefits.”
From Hormonal and Metabolic Changes of Aging and the Influence of Lifestyle Modifications (2021) · cites this paper as [13]
In the citing paper
“Some of the risks associated with T therapy include exacerbation of prostate cancer, cardiovascular-related events, hepatotoxicity, erythrocytosis, sleep apnea, and dermatological issues.12, 13”
From Hormonal and Metabolic Changes of Aging and the Influence of Lifestyle Modifications (2021) · cites this paper as [13]
In the citing paper
“Serum hepcidin was measured by enzyme-linked immunosorbent assay (Intrinsic Life Sciences) with sensitivity of 5 ng/mL, interassay coefficient of variation 12%, and range 29-254 ng/ mL in men (12,15).”
From Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point (2014) · cites this paper as [12]
In the citing paper
“We have reported that administration of supraphysiologic doses of testosterone in healthy men suppresses the iron regulatory peptide hepcidin while EPO levels remained unchanged after 20 weeks of treatment (12).”
From Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point (2014) · cites this paper as [12]
In the citing paper
“We also show that testosterone administration is associated with lower hepcidin levels in older men with mobility limitation and high burden of chronic diseases, confirming our previous observations in healthy younger and older men and demonstrating a similar magnitude of hepcidin suppression (12).”
From Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point (2014) · cites this paper as [12]
In the citing paper
“Changes in fat mass, lean body mass, and muscle strength occur within 12–16 weeks, stabilize at 6–12 months, but can marginally continue over years.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [16]
In the citing paper
“It can be concluded that the effects of testosterone on muscle strength are demonstrable after 12–20 weeks and that depending on the achieved testosterone levels, the maximum effects are attained after 6 or 12 months.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [16]
In the citing paper
“Another study using high doses of testosterone gel (starting dose 100 mg/day with possible up-titration to 150 mg/day) observed significant increases in leg press strength, chest press strength, and stair climbing power with a load within 6 months (16).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [16]
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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)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-07-08
- Volume
- 363
- Issue
- 2
- Pages
- 109-122
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3440621
- 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
- bronze
- doi.org
- 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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