Testosterone Replacement in Older Hypogonadal Men: A 12-Month Randomized Controlled Trial

Testosterone Replacement in Older Hypogonadal Men: A 12-Month Randomized Controlled Trial

A decline in testicular function is recognized as a common occurrence in older men. However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines. This study was undertaken to examine the year-long effects of testosterone administration in this patie...

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Bibliographic Details
Published in:The journal of clinical endocrinology and metabolism Vol. 82; no. 6; pp. 1661 - 1667
Main Authors: Sih, Rahmawati, Morley, John E, Kaiser, Fran E, Perry, Horace M, Patrick, Ping, Ross, Candie
Format: Journal Article
Language:English
Published: Bethesda, MD Endocrine Society 01-06-1997
Subjects:
Aged
Biological and medical sciences
Cognition - drug effects
Hand Strength
Hemoglobins - analysis
Hormones. Endocrine system
Humans
Hypogonadism - blood
Hypogonadism - drug therapy
Hypogonadism - immunology
Leptin
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Prostate-Specific Antigen - analysis
Proteins - analysis
Testosterone - therapeutic use
Time Factors
Human
Replacement therapy
Androgen
Male
Long term
Hypogonadism
Genital diseases
Testosterone
Chemotherapy
Treatment
Secondary effect
Testicular hormone
Biological effect
Sex steroid hormone
Male genital diseases
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Summary:A decline in testicular function is recognized as a common occurrence in older men. However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines. This study was undertaken to examine the year-long effects of testosterone administration in this patient population. Fifteen hypogonadal men (mean age 68 ± 6 yr) were randomly assigned to receive a placebo, and 17 hypogonadal men (mean age 65± 7 yr) were randomly assigned to receive testosterone. Hypogonadism was defined as a bioavailable testosterone <60 ng/dL. The men received injections of placebo or 200 mg testosterone cypionate biweekly for 12 months. The main outcomes measured included grip strength, hemoglobin, prostate-specific antigen, leptin, and memory. Testosterone improved bilateral grip strength (P < 0.05 by ANOVA) and increased hemoglobin (P < 0.001 by ANOVA). The men assigned to testosterone had greater decreases in leptin than those assigned to the control group (mean ± sem: −2.0 ± 0.9 ng/dL vs. 0.8 ± 0.7 ng/dL; P < 0.02). There were no significant changes in prostate-specific antigen or memory. Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study. Three of those seven withdrew because of an abnormal elevation in hematocrit. Testosterone supplementation improved strength, increased hemoglobin, and lowered leptin levels in older hypogonadal men. Testosterone may have a role in the treatment of frailty in males with hypogonadism; however, older men receiving testosterone must be carefully monitored because of its potential risks.
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ISSN:0021-972X
1945-7197
DOI:10.1210/jcem.82.6.3988