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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Current evidence consistently shows that untreated low testosterone levels are associated with an increased risk of MACE.
“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]
The Discussion (page unavailable) says some epidemiologic studies associate low testosterone with cardiovascular death. That supports a narrower association, but not the claim that evidence consistently links untreated low testosterone to increased MACE risk. The paper’s own trial instead examines cardiovascular adverse events during testosterone treatment. (LLM, conf=0.87)
Experimental — accuracy not yet measuredT supplementation is not without risk and could potentially be harmful concerning cardiovascular risk in the elderly.
“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]
The Abstract Conclusions report increased cardiovascular adverse events with testosterone gel in older men with limited mobility and a high prevalence of chronic disease. The claim's cautious wording reflects that potential risk, but its reference to the elderly more generally omits the population restriction; the same passage says the small trial and unique population prevent broader inferences. (LLM, conf=0.82)
Experimental — accuracy not yet measuredTestosterone 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.
“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]
The Discussion (page unavailable) reports that some epidemiologic studies link low testosterone levels to cardiovascular mortality, and the Results > Adverse Events section links testosterone levels during treatment to cardiovascular-related events. The paper notes diabetes and obesity among participants but does not establish a link between testosterone levels and those conditions or the other listed conditions. (LLM, conf=0.86)
Experimental — accuracy not yet measuredStudies that measure cardiovascular benefit or harm in men on testosterone therapy have returned inconsistent and controversial results.
“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 current scientific literature does not definitively demonstrate that testosterone therapy increases the risk of MACE.
“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]
Testosterone administration can increase the risk of cardiovascular adverse events.
“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]
Low vitamin D levels have been associated with frailty.
“Low vitamin D levels have been associated with frailty (133)”
From Frailty in elderly people (2013) · cites this paper as [133]
Testosterone replacement is associated with respiratory and skin/subcutaneous adverse effects and with adverse cardiovascular outcomes.
“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]
Preventing age-related hormonal decline by exogenous replacement is associated with increased risk for adverse effects in older adults.
“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]
Hormone replacement therapy often causes adverse events that outweigh its potential health benefits.
“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]
Risks of testosterone therapy include worsening prostate cancer, cardiovascular events, hepatotoxicity, erythrocytosis, sleep apnea, and skin problems.
“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]
Serum hepcidin was measured by ELISA with sensitivity 5 ng/mL, interassay CV 12%, and range 29-254 ng/mL in men.
“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]
Administration of supraphysiologic doses of testosterone in healthy men suppresses hepcidin while EPO levels remained unchanged after 20 weeks.
“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]
Testosterone administration is associated with lower hepcidin levels in older men with mobility limitation and high burden of chronic diseases.
“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]
Changes in fat mass, lean body mass, and muscle strength stabilize at 6-12 months of testosterone treatment.
“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]
Effects of testosterone on muscle strength are demonstrable after 12-20 weeks, and maximum effects are attained after 6 or 12 months depending on the achieved testosterone levels.
“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]
High doses of testosterone gel (starting dose 100 mg/day with possible up-titration to 150 mg/day) produce significant increases in leg press strength, chest press strength, and stair climbing power within 6 months.
“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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- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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