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Effects of Testosterone Treatment in Older Men
Open accessAbstract
BACKGROUND: Serum testosterone concentrations decrease as men age, but benefits of raising testosterone levels in older men have not been established. METHODS: We assigned 790 men 65 years of age or older with a serum testosterone concentration of less than 275 ng per deciliter and symptoms suggesting hypoandrogenism to receive either testosterone gel or placebo gel for 1 year. Each man participated in one or more of three trials--the Sexual Function Trial, the Physical Function Trial, and the Vitality Trial. The primary outcome of each of the individual trials was also evaluated in all participants. RESULTS: Testosterone treatment increased serum testosterone levels to the mid-normal range for men 19 to 40 years of age. The increase in testosterone levels was associated with significantly increased sexual activity, as assessed by the Psychosexual Daily Questionnaire (P<0.001), as well as significantly increased sexual desire and erectile function. The percentage of men who had an increase of at least 50 m in the 6-minute walking distance did not differ significantly between the two study groups in the Physical Function Trial but did differ significantly when men in all three trials were included (20.5% of men who received testosterone vs. 12.6% of men who received placebo, P=0.003). Testosterone had no significant benefit with respect to vitality, as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue scale, but men who received testosterone reported slightly better mood and lower severity of depressive symptoms than those who received placebo. The rates of adverse events were similar in the two groups. CONCLUSIONS: In symptomatic men 65 years of age or older, raising testosterone concentrations for 1 year from moderately low to the mid-normal range for men 19 to 40 years of age had a moderate benefit with respect to sexual function and some benefit with respect to mood and depressive symptoms but no benefit with respect to vitality or walking distance. The number of participants was too few to draw conclusions about the risks of testosterone treatment. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00799617.).
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In the citing paper
“there is accumulating evidence against a link between testosterone therapy and prostate cancer development.”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [24]
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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
“In the ‘Testosterone Trials’, treatment with testosterone improved participants’ results in the 6 min walk test compared with placebo (20.5% versus 12.6%; P = 0.003)53.”
From Sarcopenic obesity in older adults: aetiology, epidemiology and treatment strategies (2018) · cites this paper as [53]
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
“Randomized controlled trials have shown that there is not a significant increase in the rate of a prostate cancer diagnosis in older, testosterone deficient men who were treated with testosterone compared to placebo.”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [24]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“In trials, patients with low testosterone have demonstrated statistically significant improvements in erectile function, 24 sex drive, 24 anemia, 25 bone mineral density, 26 lean body mass, 27 and depressive symptoms. 24”
From Evaluation and Management of Testosterone Deficiency: AUA Guideline (2018) · cites this paper as [24]
In the citing paper
“Testosterone supplementation is also shown to benefit other aspects of health, including sexual function, physical function, vitality, quality of life and improved mood [109, 111].”
From Is There Enough Evidence for Osteosarcopenic Obesity as a Distinct Entity? A Critical Literature Review (2019) · cites this paper as [111]
In the citing paper
“Of note, potential improvements in muscle (and lean) mass may not directly result in improved muscle function214,215.”
From Sarcopenic obesity in older adults: a clinical overview (2024) · cites this paper as [214]
In the citing paper
“In the large T Trials, sexual function improved modestly with testosterone treatment,”
From Hypogonadism and male obesity: Focus on unresolved questions (2018) · cites this paper as [37]
In the citing paper
“suggesting that even older men with a relatively high comorbid burden (37% had diabetes and 15% a previous myocardial infarction) can respond to testosterone.37”
From Hypogonadism and male obesity: Focus on unresolved questions (2018) · cites this paper as [37]
In the citing paper
“In the Testosterone Trials of stringently selected symptomatic men with a baseline testosterone averaging < 9.5 nmol/L (275 ng/dL) for no apparent reason other than age, testosterone treatment had a modest benefit in sexual function, and some benefit with respect to mood and depressive symptoms (15).”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“In an intensive lifestyle randomized controlled trial (RCT) of relatively healthy obese middle-aged men, 15% weight loss increased the mean International Index of Erectile Function (IIEF) score by 3.10, which is clinically meaningful (23) and similar to the increase of 2.64 reported in the Testosterone Trials, although those men were older (15).”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“Although head-to-head studies are lacking, the efficacy reported for PDE5 inhibitors is greater than that reported for lifestyle intervention and testosterone treatment (15, 25).”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“In RCTs of middle-aged and older men, where contraindications have been rigorously excluded and treatment was carefully monitored, short-term testosterone treatment has been associated with a low risk of adverse events (15).”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“Although the trial was too small to reliably assess testosterone treatment-associated risks (15)”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“it does provide some assurance about the potential relative short-term safety of testosterone treatment in men without the previously mentioned contraindications.”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“These guideline recommendations are consistent with the exclusion criteria specified in the Testosterone Trials (15).”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
In the citing paper
“In the 12-month Testosterone Trials, the rates of adverse events were similar in the testosterone- and placebo-treated men.”
From A Perspective on Middle-Aged and Older Men With Functional Hypogonadism: Focus on Holistic Management (2017) · cites this paper as [15]
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Metadata
- Authors
- Snyder, P. J., Bhasin, S., Cunningham, G. R., Matsumoto, A. M., Stephens-Shields, A. J., Cauley, J. A., Gill, T. M., Barrett-Connor, E., Swerdloff, R. S., Wang, C., Ensrud, K. E., Lewis, C. E., Farrar, J. T., Cella, D., Rosen, R. C., Pahor, M., Crandall, J. P., Molitch, M. E., Cifelli, D., Dougar, D., Fluharty, L., Resnick, S. M., Storer, T. W., Anton, S., Basaria, S., Diem, S. J., Hou, X., Mohler, E. R., Parsons, J. K., Wenger, N. K., Zeldow, B., Landis, J. R., & Ellenberg, S. S.
- Affiliations
- University of Pennsylvania (US)
- Brigham and Women's Hospital (US)
- Baylor College of Medicine (US)
- University of Washington (US)
- From the Division of Endocrinology, Diabetes, and Metabolism (P.J.S.), the Department of Biostatistics and Epidemiology (A.J.S.-S., J.T.F., X.H., B.Z., J.R.L., S.S.E.), the Center for Clinical Epidemiology and Biostatistics (D. Cifelli, D.D., L.F.), and the Division of Cardiovascular Disease, Section of Vascular Medicine, Department of Medicine (E.R.M.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s...
- University of Pittsburgh (US)
- Yale University (US)
- University of California San Diego (US)
- The Lundquist Institute (US)
- University of Minnesota (US)
- Northwestern University (US)
- New England Research Institutes (US)
- University of Florida (US)
- Albert Einstein College of Medicine (US)
- National Institutes of Health (US)
- Emory University (US)
- ORCID
- Snyder, Peter J.
- Bhasin, Shalender
- Cunningham, Glenn R.
- Matsumoto, Alvin M.
- Cauley, Jane A.
- Gill, Thomas M.
- Barrett-Connor, Elizabeth
- Swerdloff, Ronald S.
- Wang, Christina
- Ensrud, Kristine E.
- Lewis, Cora E.
- Farrar, John T.
- Cella, David
- Crandall, Jill P.
- Molitch, Mark E.
- Resnick, Susan M.
- Storer, Thomas W.
- Anton, Stephen
- Basaria, Shehzad
- Diem, Susan J.
- Hou, Xiaoling
- Parsons, J. Kellogg
- Wenger, Nanette K.
- Zeldow, Bret
- Landis, J. Richard
- Ellenberg, Susan S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-02-18
- Volume
- 374
- Issue
- 7
- Pages
- 611-624
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5209754
- OpenAlex
- W2324158400
- Cited by
- 890
- References
- 40
- Citations by year
- 2026: 49 · 2025: 73 · 2024: 73 · 2023: 97 · 2022: 79 · 2021: 65 · 2020: 81 · 2019: 76 · 2018: 103 · 2017: 106 · 2016: 86
- FWCI
- 124.19
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (5p60dk079626-05, UL1TR000142)
- National Institute on Aging (U01AG030644, P30-AG013679, R01AG037679, K24AG021507, K07AG043587, R01 AG37679, P30AG024827, P30AG028740, P30AG021342)
- National Institute of Diabetes and Digestive and Kidney Diseases (DK079626, P60-DK-079626, P30DK079626)
- National Center for Advancing Translational Sciences
- 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 › Psychiatry and Mental health › Sexual function and dysfunction studies
- Keywords
- testosterone replacement therapy, older men, hypogonadism, testosterone gel, sexual function, erectile function, sexual desire, physical function, walking distance, vitality, depressive symptoms, mood, adverse events
- MeSH terms
- Aged, Depression, Double-Blind Method, Fatigue, Humans, Libido, Male, Reference Values, Sexual Behavior, Testosterone, Walking, Prostate-Specific Antigen, Hormone Replacement Therapy
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