PHASE II TRIAL OF MEGESTROL ACETATE AND TESTOSTERONE

这是一项为期12周的双盲随机对照试验。 受试者将随机接受甲地孕酮的联合治疗 醋酸睾丸酮醋酸酯或甲地孕酮加睾酮 Enanthate安慰剂。所有成功完成双打的受试者 盲目阶段将有资格接受甲非司酮的组合 醋酸酯和睾丸酮作为开放标记疗法治疗慢性前列腺癌 额外的12周。这项试验的主要目的是测试 假设主要积累的脂肪而不是瘦的身体质量 这发生在甲地孕酮治疗HIV相关性消瘦的过程中 醋酸甲地孕酮和甲地孕酮治疗可改善乙酸乙酯。 混合使用的睾丸酮的碳酸酯。 次要目标如下：1)比较 甲地孕酮和睾丸酮的联合应用 甲地孕酮加安慰剂对能量摄入的影响， 体重和生活质量。2)比较甲地孕醇的疗效 醋酸睾丸酮与甲地孕酮的联合应用 醋酸盐在脑下垂体轴上。4)进行安全评估 醋酸甲地孕酮和庚酸睾丸酮配伍及甲地孕酮 醋酸盐加黄体酮安慰剂。

This is a double blind, randomized, comparison trial of 12 weeks duration. Subjects will be randomized to receive either the combination of megestrol acetate and testosterone enanthate or megestrol acetate plus testosterone enanthate placebo. All subjects who successfully complete the double blind phase will be eligible to receive the combination of mefestrol acetate and testosterone enanthate as open label therapy for an additional 12 weeks. The primary objective of this trial is to test the hypothesis that the predominant accrual of fat rather than lean body mass that occurs during treatment fo HIV-associated wasting with megestrol acette may be ameliorated by treatment with megestrol acetate and testosterone enanthate in combination. The secondary objectives are as follows: 1) to compare the effects of megestrol acetate and testosterone enanthate in combination to those of megestrol acetate plus testosterone enanthate placebo on energy intake, body weight, and quality of life. 2) to compare the effects of megestol acetate and testosterone enanthate in combination to those of megestrol acetate on the pituitary adrenal axis. 4) to evaluate the safety of megestrol acetate and testosterone enanthate in combination and megestrol acetate plus testosterone enanthate placebo.