Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of luteinizing hormone (LH) pulse amplitude
研究概览
简要总结
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
详细描述
Assignment: All study subjects will undergo the same interventions.
Delivery of Interventions:
- The subject will undergo a review of their medical history, physical exam, and screening laboratories.
- A pelvic ultrasound will be performed to assess baseline follicular size.
- A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
- During the course of kisspeptin administration, subjects will
- Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
- Undergo pelvic ultrasounds (approximately 4 sessions)
- Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 18-45 years
- •Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)
- •Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- •Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
- •Negative serum hCG pregnancy test
- •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
- •If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug
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
- •Excessive alcohol consumption (>10 drinks/week)
- •Active use of illicit drugs
- •Trying to become pregnant during protocol participation
- •Breast feeding
- •History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding
研究组 & 干预措施
Kisspeptin pump
SC administration of kisspeptin for two weeks (pulsatile)
干预措施: kisspeptin 112-121 (Drug)
结局指标
主要结局
Change of luteinizing hormone (LH) pulse amplitude
时间窗: 2 weeks
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
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