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对男性良性前列腺增生症的研究

2019年3月11日 更新者：Eli Lilly and Company

在患有下尿路症状 (LUTS) 和继发于良性前列腺增生 (BPH) 的前列腺肿大的男性中评估 LY500307 每日口服剂量 24 周的 2 期临床研究

该研究的目的是确定 LY500307 是否有助于良性前列腺增生 (BPH) 的症状

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

414

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、127473
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rostov-On-Don、俄罗斯联邦、344011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg、俄罗斯联邦、196247
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 加拿大
    • British Columbia
      • Victoria、British Columbia、加拿大、V8V 3N1
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Brunswick
      • St. John、New Brunswick、加拿大、E2L 3J8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • Kitchener、Ontario、加拿大、N2N 3B9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 希腊
      • Heraklion、希腊、71110
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      • Larissa、希腊、41221
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      • Patras、希腊、26500
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      • Thessaloniki、希腊、56429
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  • 德国
      • Bad Bergzabern、德国、76887
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      • Berlin、德国、14057
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      • Hamburg、德国、20354
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      • Holzminden、德国、D-37603
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      • Marburg、德国、35039
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      • Oranienburg、德国、16515
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      • Reutlingen、德国、72764
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  • 意大利
      • Cefala、意大利、90015
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      • Firenze、意大利、50012
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      • Rome、意大利、00161
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  • 法国
      • Garches、法国、92380
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      • Lyon、法国、69437
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      • Nice、法国、06002
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      • Nimes、法国、30029
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      • Orleans、法国、45067
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      • Toulouse、法国、31059
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  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
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    • Victoria
      • Bentleigh East、Victoria、澳大利亚、3165
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      • Mentone、Victoria、澳大利亚、3194
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
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  • 美国
    • Alabama
      • Huntsville、Alabama、美国、35801
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    • Alaska
      • Anchorage、Alaska、美国、99508
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    • California
      • Glendora、California、美国、91741
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Newport Beach、California、美国、92660
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Bernardino、California、美国、92404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Diego、California、美国、92103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tarzana、California、美国、91356
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    • Colorado
      • Denver、Colorado、美国、80210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Parker、Colorado、美国、80134
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Connecticut
      • Middlebury、Connecticut、美国、06762
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Aventura、Florida、美国、33180
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bradenton、Florida、美国、34205
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Celebration、Florida、美国、34747
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      • Coral Springs、Florida、美国、33065
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Coeur d'Alene、Idaho、美国、83814
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Meridian、Idaho、美国、83642
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    • Illinois
      • Chicago、Illinois、美国、60611
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Fort Wayne、Indiana、美国、46825
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Wichita、Kansas、美国、67708
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Louisiana
      • Shreveport、Louisiana、美国、71106
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Greenbelt、Maryland、美国、20770
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Troy、Michigan、美国、48084
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Montana
      • Missoula、Montana、美国、59808
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Brooklyn、New York、美国、11215
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Garden City、New York、美国、11530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New York、New York、美国、10016
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poughkeepsie、New York、美国、12601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Concord、North Carolina、美国、28025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Salisbury、North Carolina、美国、28144
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Winston-Salem、North Carolina、美国、27103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Cincinnati、Ohio、美国、45212
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Columbus、Ohio、美国、43220
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Edmond、Oklahoma、美国、73034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Bala-Cynwyd、Pennsylvania、美国、19004
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    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Arlington、Texas、美国、76017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dallas、Texas、美国、75390
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Antonio、Texas、美国、78229
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    • Washington
      • Seattle、Washington、美国、98166
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

纳入标准：

  • 在筛查时出现良性前列腺增生 (BPH) 病史超过 6 个月。
  • 筛查时的国际前列腺症状评分 (IPSS) 大于或等于 13。
  • 筛查时经直肠超声检查的前列腺总体积大于或等于 30 毫升 (mL)。
  • 显示膀胱出口梗阻的迹象，其定义为峰值尿流率 (Qmax) 大于或等于 4 且小于或等于 15 毫升/秒 (mL/sec)（来自预排尿总膀胱容量 [通过超声评估]大于或等于 150 至小于或等于 550 毫升且最小排尿量为 125 毫升）。
  • 筛查时前列腺特异性抗原 (PSA) 大于或等于 1.4 且小于或等于 10 纳克/毫升 (ng/mL)。
  • 在筛选时通过超声波证明后排尿残留小于或等于 300 mL。

  • 未在规定期限内接受下列治疗：

    1. 筛选前服用非那雄胺或度他雄胺至少 6 个月。
    2. 筛选前至少 4 周使用任何 α-肾上腺素能拮抗剂。
    3. 筛选前至少 4 周的任何其他非实验性 BPH 疗法（包括草药制剂）。
    4. 任何其他实验性或适应症外的 BPH 疗法，例如在筛选前效果至少持续 6 个月的注射疗法。
    5. 筛选前至少 4 周的任何膀胱过度活动症治疗。
    6. 任何勃起功能障碍治疗，可能包括口服 5 型磷酸二酯酶抑制剂或装置，至少在筛选前 4 周。
  • 筛查时清晨空腹总睾酮浓度大于或等于 300 纳克/分升 (ng/dL)。
  • 如果高脂血症，根据病史，在筛选前至少 2 个月由研究者确定他汀类药物治疗稳定。

排除标准：

  • 已完成或退出本研究，或已完成或退出调查 LY500307 的任何其他研究。
  • 有任何与 BPH 相关的侵入性手术史（例如，经尿道前列腺切除术、开放式前列腺切除术和微创手术，包括热疗法、经尿道微波治疗、经尿道针消融术和支架）。

  • 患有活动性心血管疾病，证据如下：

    1. 最近的心肌梗塞、不稳定型心绞痛、中风或筛选后 6 个月内的短暂性脑缺血发作。
    2. 最近的冠状动脉介入治疗，包括冠状动脉旁路手术、经皮冠状动脉介入治疗或筛选后 6 个月内的支架置入术。
    3. 筛选后 6 个月内没有任何有效干预的书面文件的近期压力测试阳性史。
    4. 筛选后 6 个月内心脏病分类为大于或等于纽约心脏协会 (NYHA) III 级功能分类的证据。
  • 已知或怀疑有前列腺癌、乳腺癌或其他具有临床意义的肿瘤疾病（皮肤鳞状细胞癌或基底细胞癌除外）的病史。
  • 有深静脉血栓或肺栓塞病史。
  • 有中度至重度肾功能不全。
  • 血红蛋白 A1c (HbA1c) 大于 9.0%。
  • 正在接受睾酮替代疗法，或影响下丘脑-垂体-性腺轴的药物。
  • 正在接受除他汀类药物以外的高脂血症药物治疗。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：安慰剂
每天口服给药，持续 24 周
实验性的：1毫克 LY500307
药品：LY500307
每天口服给药，持续 24 周
实验性的：3毫克 LY500307
药品：LY500307
每天口服给药，持续 24 周
实验性的：10 毫克 LY500307
药品：LY500307
每天口服给药，持续 24 周
实验性的：25 毫克 LY500307
药品：LY500307
每天口服给药，持续 24 周

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
国际前列腺症状评分 (IPSS) 总分从基线到 24 周终点的变化
大体时间：基线，24 周
IPSS 总分是 IPSS 问卷中问题 1 到 7 的总分。 每个问题的评分从 0（无/无症状）到 5（常见症状），IPSS 总分范围为 0-35 分。 IPSS 问卷的分数越高代表症状越严重。
基线，24 周

次要结果测量

结果测量
措施说明
大体时间
总前列腺体积 (TPV) 从基线到 24 周终点的百分比变化
大体时间：基线，24 周
通过经直肠超声 (TRUS) 进行的 TPV 测量（毫升）是针对因良性前列腺增生 (BPH) 而出现下尿路症状 (LUTS) 的男性的既定诊断测试。
基线，24 周
峰值尿流率 (Qmax) 从基线到 24 周终点的变化
大体时间：基线，24 周
Qmax 定义为使用标准校准尿流率计测量的峰值尿流率。
基线，24 周
国际前列腺症状评分-生活质量指数 (IPSS-QoL) 从基线到 24 周终点的变化
大体时间：基线，24 周
IPSS QoL 评估参与者对以下问题的回答：“如果您的余生都像现在这样面对泌尿系统疾病，您对此有何感想？”回答选项有 Delighted (0)、Pleased (1)；基本满意 (2)； Mixed-about 同样满意和不满意 (3)；大部分不满意 (4)；不开心 (5);糟糕 (6)，总范围为 0-6。
基线，24 周
国际前列腺症状评分 (IPSS) 蓄积、排尿和夜尿亚评分从基线到 24 周终点的变化
大体时间：基线，24 周
IPSS 存储（刺激性）子分数是 IPSS 问卷中问题 2、4 和 7 的总和。 分数范围从 0（无刺激性症状）到 5（频繁的刺激性症状），刺激性子分数的 3 个问题的总子分数范围为 0 到 15。IPSS 排尿（阻塞）子分数是问题 1、3、5 的总和和 IPSS 调查问卷的 6。 分数范围从 0（无阻塞症状）到 5（经常出现阻塞症状），阻塞评分的 4 个问题的总分从 0 到 20。 Nocturia Subscore 是 IPSS 问题 7，它评估参与者在过去一个月内从他们晚上睡觉到早上起床之间起床小便的次数。 分数范围从 0 = 无； 1=1次； 2= 2 次； 3=3次； 4=4次； 5=5次或更多次。
基线，24 周
前列腺特异性抗原 (PSA) 从基线到 24 周终点的百分比变化
大体时间：基线，24 周
PSA 测量的单位是纳克每毫升 (ng/mL)。
基线，24 周
空腹总睾酮从基线到 24 周终点的变化
大体时间：基线，24 周
基线，24 周
脂质谱从基线到 24 周终点的变化
大体时间：基线，24 周
血脂谱包括低密度脂蛋白胆固醇 (LDL-C)、高密度脂蛋白胆固醇 (HDL-C) 和甘油三酯。
基线，24 周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年4月1日

初级完成 (实际的)

2011年10月1日

研究完成 (实际的)

2011年10月1日

研究注册日期

首次提交

2010年3月31日

首先提交符合 QC 标准的

2010年3月31日

首次发布 (估计)

2010年4月2日

研究记录更新

最后更新发布 (实际的)

2019年4月8日

上次提交的符合 QC 标准的更新

2019年3月11日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 10373 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
  • I1A-MC-BPAE (其他标识符：Eli Lilly and Company)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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