Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tobias Else
• Collaborator: Corcept Therapeutics
• Treatments: Mifepristone

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).