Neuropeptides in Human Reproduction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
研究概览
简要总结
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.
We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))
- •Normal blood pressure (systolic BP <140 mm Hg, diastolic BP <90 mm Hg)
- •White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range
- •Negative urine drug screen panel
- •Hemoglobin:
- •For healthy men and healthy regularly cycling women: normal
- •For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women
- •Blood urea nitrogen (BUN), creatinine, liver function tests not elevated
- •For healthy subjects: Normal reproductive function and history
- •For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2
- •For subjects with HH: All medical conditions stable and well controlled
排除标准
- •History of medication reaction requiring emergency medical attention
- •Illicit drug use
- •Consumption of more than 10 alcoholic drinks per week
- •Difficulty with blood draws
- •Currently seeking fertility, breastfeeding, or pregnant
- •For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)
- •For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition
研究组 & 干预措施
Naloxone, Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
干预措施: Kisspeptin 112-121 (Drug)
Naloxone, Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
干预措施: Naloxone (Drug)
Naloxone, Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone
干预措施: GnRH (Drug)
结局指标
主要结局
Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
时间窗: Within 30 minutes of administration
Compares response to kisspeptin on and off naloxone infusion
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