RALOXIFENE HYDROCHLORIDE & BONE TURNOVER HORMONE LEVEL IN PROSTATE SIZE

本研究是一项单中心、双盲、安慰剂对照的初步研究，旨在评价雌激素激动剂/拮抗剂雷洛昔芬对正常和性腺功能减退男性的性腺类固醇、垂体激素、骨转换、血脂、前列腺体积和性生活质量的影响。既往在绝经后女性中的研究表明，雷洛昔芬具有混合雌激素激动剂和拮抗剂作用。在骨和胆固醇代谢中，雷洛昔芬具有雌激素激动剂作用，可改善骨转换和HDL/LDL水平。 在乳腺和子宫内膜中，雷洛昔芬具有雌激素拮抗剂作用，与雌激素替代治疗相比，可导致增殖减少。因此，雷洛昔芬给药可能通过改善骨转换和脂质状态而对男性有益，而不会对前列腺产生不良影响。 这一点很重要，因为在替代治疗期间，前列腺体积增加和继发于睾酮给药的癌症值得关注。 本研究的目的是研究该药物在正常和性腺功能减退男性中的潜在疗效和安全性，为期3个月。

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.