Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Study Participants Recruited
研究概览
简要总结
The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.
详细描述
Recruitment for this trial was legally opened on February 17, 2020. When the record was first released, it incorrectly listed the recruitment status as "Not Yet Recruiting." This mistake was noticed before the first participant actually enrolled, May 5, 2021. The decision to terminate for low recruitment was made on Sept 7, 2022, approximately 30 months later, as at that point it was deemed impossible to reach the initial enrollment target of 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
- •Female patients not willing to use non-hormonal contraception for one month following treatment.
- •Women who are pregnant or breast feeding.
- •Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
- •Patients on medications that are strong CYP3A
- •Patients taking other medications metabolized by CYP3A
- •Patients who have a history of QT prolongation and patients with any recent abnormal electrocardiogram (ECG).
研究组 & 干预措施
Mifepristone
Patients will be provided a single dose of 600 milligram (mg) mifepristone to be administered orally, and subjects will be instructed to take the drug between 10PM and 11PM on Day 1.
干预措施: Mifepristone (Drug)
结局指标
主要结局
Number of Study Participants Recruited
时间窗: Up to 88 days
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. The trial opened for recruitment on February 17, 2020. Because of low enrollment, the decision to terminate was made on September 7, 2022, approximately 30 months later.
Number of Study Participants With Complete Study Data Captured
时间窗: 30 days
Because this was a feasibility trial, the goal was to see how many participants could be successfully recruited. The original intent was for the recruitment period to be for 36 months, with a target enrollment of 26 participants. Because of low enrollment, the decision to terminate was made after the trial had been open for recruitment for approximately 30 months (February 17, 2020 - September 7, 2022).
次要结局
- Peak Cortisol Measured After Mifepristone(Day 2 (day after mifepristone administration))
- Absolute ACTH After Mifepristone(Day 2 (day after mifepristone administration))
研究者
Tobias Else
Assistant Professor, Department of Internal Medicine
University of Michigan