CLINICAL STUDIES WITH LHRH ANTAGONISTS

LHRH 拮抗剂的临床研究

• 批准号: 2316008
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 18.2万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-09-30 至 1990-06-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2316008
• 关键词: dosage; drug screening /evaluation; follicle stimulating hormone; histamine release; human subject; human therapy evaluation; luteinizing hormone; peptide hormone metabolism; steroid hormone analog; testosterone

These studies have been set up to evaluate the effectiveness of a gonadotropin releasing hormone antagonist in men. The men will be given a GnRH antagonist alone (single dose studies and 21 day studies) or in conjunction with testosterone enanthate. This GnRH antagonist, supplied by Drs. Vale and Rivier, has been shown to be more 2-fold more potent than the reference compound. Therefore, this antagonist has a greater margin of safety. The studies are to be done in three parts as follows: 1. Single dose studies to establish dose response curves, monitor side effects, duration of the inhibitory effects and to select the doses to be used in the following studies. 2. 21-day studies to determine minimum inhibitory dose and compare intermittent daily doses with constant infusion of the antagonist during this phase. 3. Long term-16 week-studies to assess the efficacy of combined GnRH antagonist and testosterone. Time frame was selected in view of the 70 day sperm cycle.

已经建立了这些研究来评估 促性腺激素在男性中释放激素拮抗剂。 这些人将被给予 单独使用GNRH拮抗剂（单剂量研究和21天研究）或 与睾丸激素的结合。 这个GNRH拮抗剂，由 博士。 Vale和Rivier已显示出比 参考化合物。 因此，这个拮抗剂的边缘更大 安全。 研究应分为以下三个部分： 1。单剂量研究以建立剂量响应曲线，监测侧 效果，抑制作用的持续时间，并选择剂量 用于以下研究。 2。21天的研究以确定最小抑制剂量并比较 间歇性的每日剂量，并在 这个阶段。 3。长期16周的研究，以评估联合GnRH的疗效 拮抗剂和睾丸激素。 鉴于70天，选择了时间范围 精子周期。