RALOXIFENE HYDROCHLORIDE & BONE TURNOVER HORMONE LEVEL IN PROSTATE SIZE

这项研究是一项单中心、双盲、安慰剂对照的先导性研究，旨在评估雌激素激动剂/拮抗剂雷洛昔芬对性腺激素、脑下垂体激素、骨转换、血脂、前列腺体积和性生活质量的影响。以前对绝经后妇女的研究表明，雷洛昔芬具有雌激素激动剂和拮抗剂的混合作用。在骨骼和胆固醇代谢方面，雷洛昔芬具有雌激素激动剂作用，可以改善骨转换和高密度脂蛋白/低密度脂蛋白水平。在乳房和子宫内膜中，雷洛昔芬具有雌激素拮抗剂作用，与雌激素替代疗法相比，它可以减少细胞增殖。因此，服用雷洛昔芬可能会通过改善骨转换和血脂状况而潜在地使男性受益，而不会对前列腺癌产生不良影响。这一点很重要，因为人们担心在替代治疗期间服用睾丸素会增加前列腺癌和继发性癌症。本研究的目的是调查这种药物在3个月的疗程中对正常和性腺功能低下的男性的潜在疗效和安全性。

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.