Betydning af Eksogent østrogen på Serum Kortisol Under Synacthen-stimulering Hos Hypogonade Kvinder Med Binyrebarkinsufficiens
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in serum cortisol oral estrogen
研究概览
简要总结
The aim is to investigate impact of exogenous estrogens on cotisol Levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and withour adrenal insufficiency will be studied
详细描述
The aim is to investigate impact of exogenous estrogens on cotisol levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and without adrenal insufficiency will be studied . All patients (inclusion criteria age 18-50 years, BMI <35) will be followed for 6 months and have 3 synacthentests performed: One on transdermal estrogen (minimum 3 months), one on oral estrogens (min 3 months) and one without estrogen substitution for at least 3 months. Primary endpoint is change in serum cortisol 30 minutes after synacthen stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hypogonadism
- •Treatment with estrogen substitution
排除标准
- •Other formulations of glucocorticoid than oral hydrocortisone
- •Pregnancy
- •BMI > 35
研究组 & 干预措施
Oral estrogen
oral estrogen (2 mg/24 hours)
干预措施: Estrogen (Drug)
Transdermal estrogen
Transdermal estrogen (100ug/24 hours)
干预措施: Estrogen (Drug)
结局指标
主要结局
Change in serum cortisol oral estrogen
时间窗: Assessment will take place before and 3 months after introduction of the intervention
Change in serum cortisol 30 minutes after stimulation with synacthen in patients on oral estrogen vs no estrogen substitution
Change in serum cortisol transdermal estrogen
时间窗: Assessment will take place before and 3 months after introduction of the intervention
Change in serum cortisol 30 minutes after stimulation with synacthen in patients on transdermal estrogen vs no estrogen substitution
次要结局
未报告次要终点
研究者
Mikkel Andreassen
Consultant, PhD associate professor
Rigshospitalet, Denmark