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Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004.

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Testosterone and Aging: Clinical Research Directions.

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BRandomized Placebo-Controlled Trials of Testosterone Therapy in Older Men

Searches of the medical literature (described in Appendix A) resulted in 39 journal articles that reported the results of the 31 placebo-controlled trials of testosterone therapy in middle-aged or older men published from 1977 to 2003 (Table B-1). The committee focused its literature review on double-blinded placebo-controlled trials as they provide the best opportunity for obtaining accurate comparison data particularly when looking at qualitative endpoints such as sexual function and quality of life. Placebo-controlled trials to date have been conducted with small numbers of subjects, ranging from 6 to 108 participants, and most are of limited duration of treatment, ranging from 1 to 36 months. Of the 31 randomized trials, 18 studies administered testosterone intramuscularly, 5 gave it orally, 5 used a testosterone patch, and 3 used testosterone gel. Clinical trials of acute effects of testosterone used intravenous testosterone and are discussed in Chapter 2. Many of the randomized trials have examined healthy, community-dwelling elderly men. There have been three trials of institutionalized populations; surgical patients, rehabilitation unit patients, and nursing home patients. The remainder of the trials studied men with chronic diseases. Table B-1 provides an overview of the design features of the trials and includes information on the baseline testosterone levels of study participants as well as the testosterone levels used as entry criteria to the trial.

TABLE B-1. Randomized Placebo-Controlled Studies of Testosterone Therapy in Middle-Aged and Older Men.

TABLE B-1

Randomized Placebo-Controlled Studies of Testosterone Therapy in Middle-Aged and Older Men.

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Copyright 2004 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK216172

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