This study is a single-center, double-blind placebo controlled pilot study to evaluate the effects of an estrogen agonist/antagonist, Raloxifene, on gonadal steroids, pituitary hormones, bone turnover, lipid profiles, prostate volume and sexual quality of life in both normal and hypogonadal men. Previous studies in postmenopausal women have indicated that Raloxifene has mixed estrogen agonist and antagonist actions. In bone and cholesterol metabolism, Raloxifene has an estrogen agonist effect resulting in improved bone turnover and HDL/LDL levels. In the breast and endometrium, Raloxifene has an estrogen antagonist action resulting in a decrease in proliferation in comparison to estrogen replacement therapy. Therefore, Raloxifene administration may potentially benefit men by improving bone turnover and lipid status without adverse effects on the prostate gland. This is important because of the concern of an increase in prostate gland size and cancer secondary to administration of testosterone during replacement therapy. The goal in the present study is to investigate the potential efficacy and safety of this drug in normal and hypogonadal men over the course of 3 months.
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