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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
3
Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
University of Michigan
Ann Arbor, Michigan, United States
Number of Study Participants Recruited
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.
Time frame: Up to 88 days
Number of Study Participants With Complete Study Data Captured
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).
Time frame: 30 days
Peak Cortisol Measured After Mifepristone
Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).
Time frame: Day 2 (day after mifepristone administration)
Absolute ACTH After Mifepristone
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.
Time frame: Day 2 (day after mifepristone administration)
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