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Effects of Testosterone Treatment in Older Men
Peter J Snyder1, Shalender Bhasin, Glenn R Cunningham
1From 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 Hospital, Harvard Medical School, Boston (S. Bhasin, T.W.S., S. Basaria), and New England Research Institutes, Watertown (R.C.R.) - both in Massachusetts; the Departments of Medicine and Molecular and Cellular Biology, Division of Diabetes, Endocrinology, and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston (G.R.C.); Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs (VA) Puget Sound Health Care System, and the Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine - both in Seattle (A.M.M.); the Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.A.C.); the Division of Geriatric Medicine, Yale School of Medicine, New Haven, CT (T.M.G.); the Department of Internal Medicine and Division of Epidemiology, Department of Family Medicine and Public Health, University of California, San Diego, School of Medicine, La Jolla (E.B.-C.), the Division of Endocrinology, Harbor-UCLA Medical Center (R.S.S., C.W.), and Los Angeles Biomedical Research Institute (R.S.S., C.W.), Torrance, and the Department of Urology, Moores Comprehensive Cancer Center, University of California, San Diego (J.K.P.) - all in California; the Department of Medicine, Division of Epidemiology and Community Health, University of Minnesota (K.E.E., S.J.D.), and Minneapolis VA Health Care System (K.E.E.) - both in Minneapolis; the D
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.).
Insights
Testosterone therapy in older men improved sexual function and mood but did not significantly enhance vitality or walking ability. Further research is needed to assess long-term risks of testosterone treatment.
Area of Science:
- Gerontology
- Endocrinology
- Men's Health
Background:
- Serum testosterone levels naturally decline with aging in men.
- The therapeutic benefits of testosterone replacement in older men remain incompletely established.
- Hypoandrogenism symptoms in aging men warrant investigation into potential treatments.
Purpose of the Study:
- To evaluate the efficacy of testosterone gel in improving sexual function, physical function, and vitality in older men with low testosterone levels.
- To assess the impact of testosterone therapy on mood and depressive symptoms in elderly men.
- To determine the benefits and potential risks associated with testosterone supplementation in men aged 65 and older.
Main Methods:
- A 1-year randomized, placebo-controlled trial involving 790 men aged 65+ with serum testosterone <275 ng/dL and hypoandrogenism symptoms.
- Participants were assigned to receive either testosterone gel or placebo gel.
- The study encompassed three integrated trials: Sexual Function, Physical Function, and Vitality, with a primary outcome evaluation across all participants.
Main Results:
- Testosterone treatment normalized serum testosterone levels and significantly improved sexual activity, desire, and erectile function.
- A modest, statistically significant improvement in 6-minute walking distance was observed when data from all trials were combined.
- While vitality did not improve, testosterone therapy led to slight mood enhancement and reduced depressive symptom severity, with similar adverse event rates between groups.
Conclusions:
- Testosterone therapy in symptomatic older men moderately improved sexual function and showed some benefits for mood and depressive symptoms.
- No significant benefits were observed for vitality or walking distance in this cohort.
- The study size was insufficient to draw definitive conclusions regarding the risks associated with testosterone treatment.
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