Opioid Antagonism in Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Average Change in Mean Luteinizing Hormone (LH) Value
研究概览
简要总结
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
详细描述
Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
-
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
-
During the study, the subjects will undergo the following:
-
Undergo q10 min blood sampling for 3 hours
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Receive a naloxone bolus at the midpoint of q10 min sampling
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)
- •All medical conditions stable
- •Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- •Negative urine drug screening panel
- •Hemoglobin
- •Men on adequate testosterone replacement therapy: normal male reference range
- •Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
- •Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- •Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- •Current or recent use of a medication that affects the opioid pathway
- •Active illicit drug use
排除标准
- 未提供
研究组 & 干预措施
naloxone
one period of frequent blood sampling with IV administration of naloxone (one bolus)
干预措施: Naloxone (Drug)
结局指标
主要结局
Average Change in Mean Luteinizing Hormone (LH) Value
时间窗: Before and after treatment
Change in mean LH before vs. after naloxone bolus
Average change in mean Luteinizing Hormone (LH) value
时间窗: Before and after treatment
Change in mean LH before vs. after naloxone bolus
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