Adverse Events Associated With Testosterone Replacement in Middle-Aged and Older Men: A Meta-Analysis of Randomized, Placebo-Controlled Trials
Abstract
BACKGROUND: We performed a meta-analysis of randomized clinical trials to determine the risks of adverse events associated with testosterone replacement in older men. METHODS: The MEDLINE database was searched from 1966 to April 2004, using testosterone as the indexing term; limits included human, male, > or =45 years old, and randomized controlled trial. Of the 417 studies thus identified, 19 met the inclusion criteria: testosterone replacement for at least 90 days, men > or =45 years old with low or low-normal testosterone level, randomized controlled trial, and medically stable men. Odds ratios (ORs) were pooled using a random effects model, assuming heterogeneous results across studies, and were weighted for sample size. RESULTS: In the 19 studies that met eligibility criteria, 651 men were treated with testosterone and 433 with placebo. The combined rate of all prostate events was significantly greater in testosterone-treated men than in placebo-treated men (OR = 1.78, 95% confidence interval [CI], 1.07-2.95). Rates of prostate cancer, prostate-specific antigen (PSA) >4 ng/ml, and prostate biopsies were numerically higher in the testosterone group than in the placebo group, although differences between the groups were not individually statistically significant. Testosterone-treated men were nearly four times as likely to have hematocrit >50% as placebo-treated men (OR = 3.69, 95% CI, 1.82-7.51). The frequency of cardiovascular events, sleep apnea or death was not significantly different between the two groups. CONCLUSIONS: Testosterone replacement in older men was associated with a significantly higher risk of detection of prostate events and of hematocrit >50% than was placebo; hematocrit increase was the most frequent adverse event associated with testosterone replacement. These data reaffirm the need to monitor hematocrit, PSA, and digital examination of the prostate during testosterone replacement in older men.
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One meta-analysis estimated that 85,862 men would be required in each arm of a 1-year experimental study to identify a 20% increased risk of prostate cancer with 80% power at a 5% significance level.
“As an example, one meta-analyses evaluating prostate-specific events associated with T supplementation estimated that 85,862 men would be required in each arm of a 1-year experimental study to identify a 20% increased risk of prostate cancer with 80% power at a 5% significance level.142”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [142]
In one study, testosterone supplementation was associated with an increased risk of hematocrits >50%, with an odds ratio of 3.7 and a 95% confidence interval of 1.82-7.51.
“For example, T supplementation is associated with an increased risk of hematocrits > 50%, with an odds-ratio of 3.7 and a 95% confidence interval of 1.82–7.51 in one study.142”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [142]
A meta-analysis found that testosterone replacement versus placebo raised the odds of a prostate event and of hematocrit above 50% by 1.78 and 3.69 times, respectively.
“A meta-analysis analyzing adverse events of T therapy reported that in those who received T replacement therapy compared to placebo, the odds of developing a prostate event or having a hematocrit >50% were 1.78 and 3.69 times greater, respectively.221”
From Hormonal and Metabolic Changes of Aging and the Influence of Lifestyle Modifications (2021) · cites this paper as [221]
Increased red blood cell mass (erythrocytosis) is the most common adverse event associated with testosterone therapy in clinical practice and in testosterone trials.
“Increased red blood cell mass (erythrocytosis) is the most common adverse event associated with testosterone therapy in clinical practice and in testosterone trials (2,3).”
From Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point (2014) · cites this paper as [2]
Meta-analyses of randomized testosterone trials have reported very low frequency of neuro-occlusive events.
“The meta-analyses of randomized testosterone trials have, however, reported very low frequency of neuro-occlusive events (2,3,20).”
From Testosterone induces erythrocytosis via increased erythropoietin and suppressed hepcidin: evidence for a new erythropoietin/hemoglobin set point (2014) · cites this paper as [2]
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- Authors
- Calof, O. M., Singh, A. B., Lee, M. L., Kenny, A. M., Urban, R. J., Tenover, J. L., & Bhasin, S.
- Affiliations
- Boston University (US)
- Charles R. Drew University of Medicine and Science (US)
- The University of Texas Medical Branch at Galveston (US)
- Emory University (US)
- Corresponding author
- Calof, O. M.
- Venue
- The Journals of Gerontology Series A: Biological Sciences and Medical Sciences
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-11-01
- Volume
- 60
- Issue
- 11
- Pages
- 1451-1457
- ISSN
- 1079-5006 (ISSN-L)
- 1758-535X
- OpenAlex
- W2075118988
- Cited by
- 728
- References
- 6
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 19 · 2023: 29 · 2022: 27 · 2021: 25 · 2020: 38 · 2019: 29 · 2018: 43 · 2017: 40 · 2016: 42 · 2015: 68 · 2014: 61 · 2013: 61 · 2012: 44
- FWCI
- 2.36
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journals of Gerontology Series A (publishedVersion)
- PubMed (publishedVersion)
- 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 › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Keywords
- testosterone replacement therapy, adverse events, older men, middle-aged men, hypogonadism, prostate cancer, prostate-specific antigen, prostate biopsy, hematocrit, cardiovascular events, sleep apnea, mortality
- MeSH terms
- Aged, Cardiovascular System, Hematocrit, Humans, Lipids, Male, Middle Aged, Placebos, Prostate, Sensitivity and Specificity, Testosterone, Hormone Replacement Therapy
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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