Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin
研究概览
简要总结
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
详细描述
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Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
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Delivery of Interventions:
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Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
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On the day of the inpatient study, the subjects will
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Undergo q10 min blood sampling for 6 hours,
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Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
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Undergo q10 min blood samplings for another 6 hours,
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Receive a single GnRH IV bolus at hour 51.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age 18 years and older,
- •Confirmed diagnosis of HH with
- •Low testosterone or estradiol,
- •Low or low-normal gonadotropin levels,
- •Thyroid stimulating hormone (TSH) and prolactin within the reference range,
- •Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
- •All other medical conditions stable and well controlled,
- •No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
- •No history of a medication reaction requiring emergency medical care,
- •No illicit drug use,
- •No excessive alcohol consumption (<10 drinks/week),
- •Normal blood pressure (BP), (systolic BP < 140 mm Hg, diastolic < 90 mm Hg),
- •White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
- •Prolactin below 110% of the upper limit of the reference range,
- •Hemoglobin
- •Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
- •Men: on adequate testosterone replacement therapy: normal male reference range,
- •Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
- •For women,
- •Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),
- •Not breastfeeding and not pregnant.
研究组 & 干预措施
Experimental: kisspeptin, GnRH
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
干预措施: kisspeptin 112-121 (Drug)
Experimental: kisspeptin, GnRH
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
干预措施: GnRH (Drug)
结局指标
主要结局
Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin
时间窗: 52 hours
Change in LH amplitude before, during and after kisspeptin administration
Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin
时间窗: 52 hours
Change in LH amplitude before, during and after kisspeptin administration
次要结局
- Average change in LH pulse frequency in response to kisspeptin(52 hours)
- Average Change in LH Pulse Frequency in Response to Kisspeptin(52 hours)
研究者
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Massachusetts General Hospital; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Massachusetts General Hospital