Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in peripheral oxytocin concentration from 0 to 24 hours
研究概览
简要总结
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:
- Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
- Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AVD Group:
- •Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
- •Healthy Control Group Adults 16-65 years old
- •Exclusion Criteria for all participants:
- •History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease
- •Pregnancy or breastfeeding within last 8 weeks
- •Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety
排除标准
- 未提供
研究组 & 干预措施
Arginine-vasopressin deficiency
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency
干预措施: Norethindrone Acetate-Ethinyl Estradiol (Drug)
Healthy control
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.
干预措施: Norethindrone Acetate-Ethinyl Estradiol (Drug)
结局指标
主要结局
Change in peripheral oxytocin concentration from 0 to 24 hours
时间窗: Time points: time 0 min (baseline) and 24 hours
Change in peripheral oxytocin concentration from 0 to 24 hours
次要结局
- Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls(From time 0 min (baseline) to 48 hours)
研究者
Elizabeth Austen Lawson
Associate Professor of Medicine
Massachusetts General Hospital