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临床试验/NCT01438073
NCT01438073已完成1 期

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
96
试验地点
1
主要终点
Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion

研究概览

简要总结

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

详细描述

Please contact study staff for a detailed description.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

kisspeptin, GnRH

Experimental

24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)

干预措施: kisspeptin 112-121 (Drug)

kisspeptin, GnRH

Experimental

24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)

干预措施: GnRH (Drug)

结局指标

主要结局

Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion

时间窗: 24 hours

次要结局

  • Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females)(24 hours)
  • Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males)(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Massachusetts General Hospital

研究点 (1)

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