Administration of Kisspeptin in Patients With Hyperprolactinemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
研究概览
简要总结
The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •confirmed diagnosis of elevated levels of prolactin measured via blood test,
- •no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
- •no history of a medication reaction requiring emergency medical care,
- •no illicit drug use or excessive alcohol consumption (>10 drinks/week),
- •not currently seeking fertility, breastfeeding or pregnant,
- •no history of bilateral oophorectomy,
- •willing to complete a dopamine agonist washout and/or oral contraceptive washout,
- •normal physical exam and laboratory studies within protocol reference range.
研究组 & 干预措施
Intravenous Kisspeptin
Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV).
干预措施: Kisspeptin 112-121 (Drug)
Intravenous Kisspeptin
Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV).
干预措施: GnRH (Drug)
Subcutaneous Kisspeptin
Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.
干预措施: Kisspeptin 112-121 (Drug)
结局指标
主要结局
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
时间窗: Up to 14 days
Average change in LH pulse frequency at baseline and during kisspeptin IV administration
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin
时间窗: Evaluated over eight days
Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration
次要结局
- Average Change in LH Pulse Amplitude(Up to 14 days)
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