Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Tobias Else

Status and phase: Terminated; Phase 2

Conditions: Central Adrenal Insufficiency; Mifepristone

Treatments: Drug: Mifepristone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04588688

HUM00160641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Mifepristone

Experimental group

Description:

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.

Treatment:

Drug: Mifepristone