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The Journal of Clinical Endocrinology & Metabolism Vol. 82, No. 6 1661-1667
Copyright © 1997 by The Endocrine Society


Reproductive Endocrinology

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

Rahmawati Sih, John E. Morley, Fran E. Kaiser, Horace M. Perry, III, Ping Patrick and Candie Ross

Division of Geriatric Medicine, St. Louis University Health Sciences Center (R.S., J.E.M., F.E.K., H.M.P., P.P., C.R.), St. Louis, Missouri 63104; and Geriatric Research and Education Clinical Center, St. Louis-Veterans Affairs Medical Center (R.S., J.E.M., H.M.P.), St. Louis, Missouri 63125

Address all correspondence and requests for reprints to: Rahmawati Sih, Division of Geriatric Medicine, St. Louis University Health Sciences Center, 1402 South Grand Boulevard, Room M238, St. Louis, Missouri 63104.

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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