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一项针对低睾酮男性的研究，以测量睾酮溶液对睾酮水平、性欲和能量的影响

2015年11月24日更新者：Eli Lilly and Company

一项随机、双盲、安慰剂对照的平行研究，带有开放标签扩展，以评估睾酮溶液对性腺功能减退男性的总睾酮、性欲和能量的影响

这项研究的主要目的是评估睾酮溶液是否可以将睾酮激素水平提高到正常范围内，并且还可以提高睾酮水平低和性唤起、兴趣降低的男性的性唤起、兴趣和动力和/或能量水平和/或减少能量。该研究将持续约 16 周，随后是可选的 24 周开放标签治疗阶段，以调查睾酮溶液的长期安全性。

研究概览

地位

完全的

条件

性腺机能减退

干预/治疗

研究类型

介入性

注册 (实际的)

715

阶段

第三阶段

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

加拿大
- Alberta
  - Calgary、Alberta、加拿大
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- British Columbia
  - Victoria、British Columbia、加拿大
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- Ontario
  - Barrie、Ontario、加拿大
    - 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.
  - Burlington、Ontario、加拿大
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  - Kingston、Ontario、加拿大
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  - Kitchener、Ontario、加拿大
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  - London、Ontario、加拿大
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- Quebec
  - Sherbrooke、Quebec、加拿大
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大韩民国
- - Goyang-Si、大韩民国
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  - Jeon Ju-City、大韩民国
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  - Kwang Ju、大韩民国
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  - Pusan、大韩民国
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  - Seoul、大韩民国
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德国
- - Berlin、德国
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  - Halle、德国
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  - Hamburg、德国
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  - Hettstedt、德国
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  - Holzminden、德国
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  - Marburg、德国
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  - Münster、德国
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意大利
- - Ancona、意大利
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  - Bergamo、意大利
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  - Bologna、意大利
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  - Catania、意大利
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  - Firenze、意大利
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  - Rome、意大利
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  - Rozzano、意大利
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  - Torino、意大利
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波多黎各
- - San Juan、波多黎各
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美国
- Alabama
  - Homewood、Alabama、美国
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- Arizona
  - Chandler、Arizona、美国
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  - Glendale、Arizona、美国
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  - Mesa、Arizona、美国
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  - Phoenix、Arizona、美国
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  - Tempe、Arizona、美国
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  - Tucson、Arizona、美国
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- California
  - Escondido、California、美国
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  - Irvine、California、美国
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  - Los Angeles、California、美国
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  - Spring Valley、California、美国
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- Colorado
  - Colorado Springs、Colorado、美国
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- Florida
  - Coral Springs、Florida、美国
    - 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.
  - Daytona Beach、Florida、美国
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  - Fort Lauderdale、Florida、美国
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  - Jacksonville、Florida、美国
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  - Oviedo、Florida、美国
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  - Plantation、Florida、美国
    - 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.
  - St. Petersburg、Florida、美国
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- Idaho
  - Idaho Falls、Idaho、美国
    - 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
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- Illinois
  - Crystal Lake、Illinois、美国
    - 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
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  - Indianapolis、Indiana、美国
    - 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
  - Des Moines、Iowa、美国
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- Kansas
  - Topeka、Kansas、美国
    - 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
    - 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
    - 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.
- Missouri
  - Springfield、Missouri、美国
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- Nevada
  - Las Vegas、Nevada、美国
    - 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 Jersey
  - Englewood、New Jersey、美国
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  - Toms River、New Jersey、美国
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- North Carolina
  - Raleigh、North Carolina、美国
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  - Wilmington、North Carolina、美国
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- Ohio
  - Columbus、Ohio、美国
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- Pennsylvania
  - Bala Cynwyd、Pennsylvania、美国
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- South Carolina
  - Greer、South Carolina、美国
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  - Mt. Pleasant、South Carolina、美国
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- Tennessee
  - Kingsport、Tennessee、美国
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- Texas
  - Austin、Texas、美国
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  - Houston、Texas、美国
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- Utah
  - Clinton、Utah、美国
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- Washington
  - Bellevue、Washington、美国
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  - Seattle、Washington、美国
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  - Spokane、Washington、美国
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英国
- - Barnsley、英国
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- Greater London
  - London、Greater London、英国
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- Manchester
  - Hathersage Road、Manchester、英国
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西班牙
- - Aravaca、西班牙
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  - Barcelona、西班牙
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  - Coslada、西班牙
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  - La Coruña、西班牙
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  - Madrid、西班牙
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  - Majadahonda、西班牙
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阿根廷
- - Buenos Aires、阿根廷
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  - Caba、阿根廷
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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

18年及以上 (成人、OLDER_ADULT)

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 2 次筛查访视中，每次总睾酮水平 <300 纳克每分升 (ng/dL) [10.4 纳摩尔每升 (nmol/L)]
至少有 1 种睾丸激素缺乏症的症状，其中必须包括精力下降或性欲下降
筛查时前列腺特异性抗原 (PSA) <4 纳克/毫升 (ng/ml)

排除标准：

在研究期间任何时间怀孕或怀孕的性伴侣
在筛选前的 6 个月内使用长效肌肉注射 (IM) 十一酸睾酮或睾酮丸
筛选时身体质量指数 (BMI) >37 千克每平方米 (kg/m^2)
严重的下尿路症状和/或显着的前列腺肿大
筛选时催乳素实验室测试结果 >30 ng/mL
筛选时血红蛋白 A1c (HbA1c) >11%
筛选时血细胞比容≥50%（在高海拔地区>54%）
当前使用任何会干扰睾丸激素的药物、草药和/或营养补充剂
可能会影响睾酮吸收（例如湿疹）或因局部睾酮替代疗法而加剧的腋下皮肤病
目前正在接受癌症化疗或抗雄激素治疗
长期使用全身性糖皮质激素（筛选前 3 个月内使用 >14 天）；筛选前 12 个月内使用非睾酮合成代谢类固醇
参加某项运动的竞技运动员可能会接受合成代谢类固醇筛查
筛选前 12 个月内使用雌激素剂的历史
筛选前最后 6 个月内促黄体激素释放激素拮抗剂或激动剂治疗史
筛选前 3 个月内接受过克罗米芬或其他抗雌激素治疗的病史
筛选前 3 个月内使用过非那雄胺，或筛选前 6 个月内使用过度他雄胺
目前正在使用华法林或苯丙香豆素
频繁使用阿片类药物的历史：筛选前 30 天内的任何一周内 >1 次/周
目前使用多巴胺受体激动剂（卡麦角林、培高利特、溴隐亭）
筛选前 6 个月内有严重的中枢神经系统损伤或疾病（包括中风、脊髓损伤或多发性硬化症）病史
筛选时收缩压 >170 或 <90 毫米汞柱 (mm Hg) 或舒张压 >100 或 <50 毫米汞柱或有恶性高血压病史
根据布劳恩瓦尔德不稳定心绞痛分类定义的不稳定型心绞痛病史或过去 6 个月性交期间发生的心绞痛
筛选后 90 天内有以下任何冠状动脉疾病的病史：心肌梗塞、冠状动脉旁路移植手术、经皮冠状动脉介入治疗（血管成形术或支架置入术）
有任何室上性心律失常伴有不受控制的心室反应 [平均心率 > 100 次/分钟 (bpm)] 在休息时，或有任何自发性或诱发持续性室性心动过速（心率 > 100 bpm ≥ 30 秒）的病史，或使用自动体内心律转复除颤器
有心脏骤停病史
在筛选前 6 个月内表现出充血性心力衰竭 [纽约心脏协会 (NYHA) 2 级或以上] 的任何证据
筛选前 90 天内出现新的显着心脏传导缺陷
筛选时直肠指检期间临床怀疑（或病史）前列腺癌
已知或疑似乳腺癌（或乳腺癌病史）或其他活动性癌症（非黑素性皮肤癌除外）
在筛选时表现出严重肾功能损害的证据 [肌酐清除率 <30 毫升/分钟 (mL/min)，由 Cockcroft-Gault 公式确定]
在筛选时表现出严重肝病史或肝功能损害的临床证据
有人类免疫缺陷病毒（HIV）感染史
严重的睡眠呼吸暂停
未经治疗的甲状腺功能减退症、皮质醇增多症或其他导致低能量或疲劳症状的显着内分泌病（性腺功能减退症除外）

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：平行线
屏蔽：三倍

手臂数量

武器和干预

参与者组/臂	干预/治疗
PLACEBO_COMPARATOR：安慰剂溶液安慰剂溶液每天局部应用一次，持续 12 周。	药品：安慰剂溶液局部给药于腋窝。
实验性的：睾酮溶液睾酮溶液 60 毫克 (mg) 局部应用，每天一次，可能滴定至每天 30 毫克 (mg/天) 或最高 120 毫克/天，持续 12 周，并可选择延长 24 周。	药品：睾酮溶液局部给药于腋窝。其他名称： LY900011 亚克龙睾酮溶液 2%

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
第 12 周时总血清睾酮浓度在正常范围内的参与者人数大体时间：第 12 周	血清总睾酮的正常范围定义为 300 至 1050 毫微克/分升 (ng/dL)。	第 12 周

次要结果测量

结果测量	措施说明	大体时间
性唤起、兴趣和驱动 (SAID) 量表分数从基线到第 12 周的变化大体时间：基线，第 12 周	SAID 量表是一种自我管理的工具，用于评估患有症状性性腺功能减退症的男性的性唤起、兴趣和性欲。 SAID 由 5 个问题组成，评分从 1 到 5，“5”对应于更高水平的性唤起、兴趣或驱动力。 SAID 量表总分是通过将项目分数相加并将总和线性转换为 0 到 100 的量表来计算的，较高的分数对应于较高的性唤起、兴趣和驱动力。使用治疗组和基线值作为协变量的协方差分析 (ANCOVA) 计算相对于基线的最小二乘法 (LS) 平均变化。	基线，第 12 周
性腺功能减退症能量日记 (HED) 分数从基线到第 12 周的变化大体时间：基线，第 12 周	HED 是一种自我管理的仪器，用于评估患有症状性性腺功能减退症的男性的实时能量水平。它由 2 个问题组成，评分范围从 0 到 10，“10”对应“充满活力”或“一点也不累”（疲劳量表是反向映射的，因为它是用“10”收集的”对应于“极度疲劳”）。问卷连续 7 天每天完成 3 次（形成 6 个独特的项目）。项目分数是通过 7 天内每个项目的平均值计算得出的。如果某项目缺失超过 2 天，则项目得分缺失。总分是通过将项目分数相加并将总和线性转换为 0 到 100 的比例来计算的，分数越高，能量越大。如果缺少任何项目分数，则总分数将丢失。使用治疗组和基线值作为协变量的 ANCOVA 计算相对于基线的 LS 平均变化。	基线，第 12 周
前列腺特异性抗原 (PSA) >4 纳克/毫升 (ng/mL) 的参与者人数大体时间：双盲基线，第 12 周，开放标签基线，第 36 周		双盲基线，第 12 周，开放标签基线，第 36 周

其他结果措施

结果测量	措施说明	大体时间
国际前列腺症状总分 (IPSS) 相对于基线的变化大体时间：基线、第 12 周、第 36 周	IPSS 是一种自我管理的工具，用于评估下尿路症状的严重程度。 IPSS 由 7 个问题组成，评分范围从 0（无/无症状）到 5（经常出现症状），总分范围为 0 到 35。 IPSS 问卷的分数越高代表症状越严重。使用治疗组和基线值作为协变量的 ANCOVA 计算相对于基线的 LS 平均变化。	基线、第 12 周、第 36 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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Brock G, Heiselman D, Maggi M, Kim SW, Rodriguez Vallejo JM, Behre HM, McGettigan J, Dowsett SA, Hayes RP, Knorr J, Ni X, Kinchen K. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study. J Urol. 2016 Mar;195(3):699-705. doi: 10.1016/j.juro.2015.10.083. Epub 2015 Oct 20.

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

2013年5月1日

初级完成 (实际的)

2014年10月1日

研究完成 (实际的)

2015年4月1日

研究注册日期

首次提交

2013年3月19日

首先提交符合 QC 标准的

2013年3月19日

首次发布 (估计)

2013年3月22日

研究记录更新

最后更新发布 (估计)

2015年12月28日

上次提交的符合 QC 标准的更新

2015年11月24日

最后验证

2015年11月1日

安慰剂溶液的临床试验

Institut Pasteur de Lille

完全的

专为倦怠前准备的营养品 (WELBI)

烧完 | 心理障碍

法国
City of Hope Medical Center
National Cancer Institute (NCI)

主动，不招人

疫苗治疗可降低接受供体干细胞移植的恶性血液病患者的巨细胞病毒事件频率

造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤

美国
University of Zurich

招聘中

围手术期绘画艺术疗法（LOM® Solution Centered Art Therapy）对手术患者的影响

创伤后应激障碍 | 胰腺癌 | 抑郁、焦虑 | 下消化道良性肿瘤

瑞士
LG Chem

主动，不招人

YVOIRE Y-Solution 540 的有效性和安全性

鼻唇沟皱纹

中国
Mila (bMotion Technologies)

完全的

对有影响阅读的特定学习障碍儿童的阅读技能进行严肃游戏的节奏训练

阅读障碍 | 学习障碍 | 学习障碍，具体 | 特定的学习障碍，伴有阅读障碍

法国
University of Zurich

完全的

Provent® 对持续气道正压通气治疗停药期间阻塞性睡眠呼吸暂停的影响

阻塞性睡眠呼吸暂停

瑞士, 英国
Institute for the Study of Urological Diseases,...

尚未招聘

用于 ED 治疗的 LiST 加 PRP 注射疗法与 LiST 单一疗法

勃起功能障碍
Asahi Kasei Pharma America Corporation

撤销

ART-123 在脓毒症和凝血病患者中的安全性和有效性 (Scarlet2)

败血症和凝血病
XVIVO Perfusion

招聘中

常温离体肺灌注 (EVLP) 作为供体肺移植评估的 All Comers Registry

肺移植

美国
Kinderkrankenhaus auf der Bult

未知

无线微电流刺激小儿深部皮肤烧烫伤的治疗效果 (ELSTHER)

烧伤

德国

参与者组/臂	干预/治疗
PLACEBO_COMPARATOR：安慰剂溶液安慰剂溶液每天局部应用一次，持续 12 周。	药品：安慰剂溶液局部给药于腋窝。
实验性的：睾酮溶液睾酮溶液 60 毫克 (mg) 局部应用，每天一次，可能滴定至每天 30 毫克 (mg/天) 或最高 120 毫克/天，持续 12 周，并可选择延长 24 周。	药品：睾酮溶液局部给药于腋窝。其他名称： LY900011 亚克龙睾酮溶液 2%

一项针对低睾酮男性的研究，以测量睾酮溶液对睾酮水平、性欲和能量的影响

一项随机、双盲、安慰剂对照的平行研究，带有开放标签扩展，以评估睾酮溶液对性腺功能减退男性的总睾酮、性欲和能量的影响

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

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

安慰剂溶液的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Panama

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点