Clinical trial NCT04588688: Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Official title: Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Central Adrenal Insufficiency
Mifepristone
Keywords: Insulin Tolerance Test
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Corcept Therapeutics
First posted: 2020-10-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (1 of the following):

* Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
* Are scheduled to complete ITT.
* Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of Study Participants Recruited
timeFrame: Up to 88 days
measure: Number of Study Participants With Complete Study Data Captured
timeFrame: 30 days
Secondary outcomes:
measure: Peak Cortisol Measured After Mifepristone
timeFrame: Day 2 (day after mifepristone administration)
measure: Absolute ACTH After Mifepristone
timeFrame: Day 2 (day after mifepristone administration)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tobias Else, MD
role: PRINCIPAL_INVESTIGATOR
References: