Reference Ranges for Testosterone in Men Generated Using Liquid Chromatography Tandem Mass Spectrometry in a Community-Based Sample of Healthy Nonobese Young Men in the Framingham Heart Study and Applied to Three Geographically Distinct Cohorts
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CONTEXT: Reference ranges are essential for partitioning testosterone levels into low or normal and making the diagnosis of androgen deficiency. We established reference ranges for total testosterone (TT) and free testosterone (FT) in a community-based sample of men. METHODS: TT was measured using liquid chromatography tandem mass spectrometry in nonobese healthy men, 19-40 yr old, in the Framingham Heart Study Generation 3; FT was calculated. Values below the 2.5th percentile of reference sample were deemed low. We determined the association of low TT and FT with physical dysfunction, sexual symptoms [European Male Aging Study (EMAS) only], and diabetes mellitus in three cohorts: Framingham Heart Study generations 2 and 3, EMAS, and the Osteoporotic Fractures in Men Study. RESULTS: In a reference sample of 456 men, mean (sd), median (quartile), and 2.5th percentile values were 723.8 (221.1), 698.7 (296.5), and 348.3 ng/dl for TT and 141. 8 (45.0), 134.0 (60.0), and 70.0 pg/ml for FT, respectively. In all three samples, men with low TT and FT were more likely to have slow walking speed, difficulty climbing stairs, or frailty and diabetes than those with normal levels. In EMAS, men with low TT and FT were more likely to report sexual symptoms than men with normal levels. Men with low TT and FT were more likely to have at least one of the following: sexual symptoms (EMAS only), physical dysfunction, or diabetes. CONCLUSION: Reference ranges generated in a community-based sample of men provide a rational basis for categorizing testosterone levels as low or normal. Men with low TT or FT by these criteria had higher prevalence of physical dysfunction, sexual dysfunction, and diabetes. These reference limits should be validated prospectively in relation to incident outcomes and in randomized trials.
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Multiple studies attempted to establish a reference range for total T in young men, ending in diverse intervals for all different cohorts.
“Multiple studies attempted to establish a reference range to achieve generally accepted values for total T in young men, ending in diverse intervals for all different cohorts [174–177].”
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 [177]
Reference ranges for free T may not be universally valid; different methods and cohort characteristics may generate different intervals.
“Finally, for both measured and calculated free T, reference ranges may not be universally valid. Depending on the method to assess free T as well as characteristics of the cohort, different intervals may be generated [177, 229].”
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 [177]
Numerous studies have consistently found age-dependent decreases in testosterone.
“Numerous studies have consistently identified age-dependent decreases in T.”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [38]
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Self-citationLC–MS/MS analysis of steroids in the clinical laboratory
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Low testosterone is associated with disability in men with multiple sclerosis
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INTERDISCIPLINARY CLINICAL PRACTICE GUIDELINES "MANAGEMENT OF OBESITY AND ITS COMORBIDITIES"
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Androgen Deficiency Exacerbates High-Fat Diet-Induced Metabolic Alterations in Male Mice
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Recovery of Endocrine and Inflammatory Mediators Following an Extended Energy Deficit
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Self-citationSex differences in vascular aging in response to testosterone
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The risk of TESE-induced hypogonadism: a systematic review and meta-analysis
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Female sex protects from organ failure and sepsis after major trauma haemorrhage
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A multi-step, dynamic allosteric model of testosterone's binding to sex hormone binding globulin
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The Laboratory Diagnosis of Testosterone Deficiency
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Sildenafil increases serum testosterone levels by a direct action on the testes
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Self-citationBenefits and Risks of Testosterone Treatment in Men with Age-Related Decline in Testosterone
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Self-citationClinical applications of LC-MS sex steroid assays
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Self-citationRecommendations on the diagnosis, treatment and monitoring of testosterone deficiency in men
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Acrosome reaction is impaired in spermatozoa of obese men: a preliminary study
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TRPM8-androgen receptor association within lipid rafts promotes prostate cancer cell migration
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EMAS position statement: Testosterone replacement therapy in the aging male
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Anogenital distance is determined during early gestation in humans
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Anabolic-Androgenic Steroid Use in Sports, Health, and Society
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Self-citationTestosterone deficiency in adults and corresponding treatment patterns across the globe
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Current topics in testosterone replacement of hypogonadal men
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Do low testosterone levels contribute to ill-health during male ageing?
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Adverse health effects of testosterone deficiency (TD) in men
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Ascertainment of Testosterone Prescribing Practices in the VA
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Self-citationAndrogens, aging, and prostate health
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Factors Associated With Circulating Sex Hormones in Men
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Self-citationEpidemiology of Male Hypogonadism
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The future of sperm: a biovariability framework for understanding global sperm count trends
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- Authors
- Bhasin, S., Pencina, M., Jasuja, G. K., Travison, T. G., Coviello, A., Orwoll, E., Wang, P. Y., Nielson, C., Wu, F., Tajar, A., Labrie, F., Vesper, H., Zhang, A., Ulloor, J., Singh, R., D'Agostino, R., & Vasan, R. S.
- Affiliations
- Boston University (US)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2011-08
- Volume
- 96
- Issue
- 8
- Pages
- 2430-2439
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC3146796
- OpenAlex
- W2165100613
- Cited by
- 355
- References
- 54
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 11 · 2023: 18 · 2022: 32 · 2021: 21 · 2020: 22 · 2019: 28 · 2018: 29 · 2017: 20 · 2016: 34 · 2015: 30 · 2014: 32 · 2013: 36 · 2012: 19
- FWCI
- 23.38
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Funders
- National Institutes of Health (n01hc25195-41-0-1, 5p30ag031679-15)
- National Institute on Aging (R01AG031206, 5 P30 AG031679, U01AG018197, U01AG027810, P30-AG031679)
- National Heart, Lung, and Blood Institute (N01‐HC25195, N01-HC-025195)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01AR045583, U01AR045580, U01AR045632, U01AR045654, U01AR045614, U01AR045647)
- National Center for Research Resources (UL1RR024140)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Reproductive Medicine › Sperm and Testicular Function
- Keywords
- testosterone, reference values, androgen deficiency, free testosterone, total testosterone, physical dysfunction, sexual dysfunction, diabetes mellitus, frailty, young men, community sample
- MeSH terms
- Adult, Chemistry, Clinical, Chromatography, Liquid, Humans, Hypogonadism, Male, Massachusetts, Reference Values, Residence Characteristics, Risk Factors, Testosterone, Cohort Studies, Prevalence, Tandem Mass Spectrometry, Young Adult
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