NCT07224490招募中1 期
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
Stephanie B. Seminara, MD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in mean luteinizing hormone (LH) amplitude between cases and controls
研究概览
简要总结
The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.
详细描述
Delivery of Interventions:
- Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg
- Blood sampling before and after administration of kisspeptin (two timepoints total)
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
- 否
入选标准
- •Female (ages 18-45 years) or Male (ages 18-60 years)
- •No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
- •For women, negative serum hCG pregnancy test
- •For cases, diagnosis of post-covid-19 syndrome
- •For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome
排除标准
- •Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol or the interpretation of results
- •Active use of illicit drugs (not including marijuana)
- •For women,
- •Trying to become pregnant during protocol participation
- •Breast feeding
- •Surgical or natural menopause
研究组 & 干预措施
Kisspeptin administration
Experimental
Single bolus of kisspeptin
干预措施: Kisspeptin 112-121 (Drug)
结局指标
主要结局
Difference in mean luteinizing hormone (LH) amplitude between cases and controls
时间窗: Day of study visit (one to two hours)
Difference between cases and controls of mean LH amplitude in response to kisspeptin
次要结局
未报告次要终点
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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