NCT04588688

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Terminated Phase 2 Results posted Last updated 12 June 2023

What this trial tests

Phase 2 trial testing Mifepristone in Central Adrenal Insufficiency in 3 participants. Terminated before completion.

Timeline

5 May 2021

Primary endpoint
1 August 2021

1 August 2021

Quick facts

Lead sponsor	Tobias Else
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	3
Start date	5 May 2021
Primary completion	1 August 2021
Estimated completion	1 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Mifepristone (MIFEPRISTONE) — full drug profile →

Conditions studied

• Central Adrenal Insufficiency — all drugs for Central Adrenal Insufficiency →
• Mifepristone — all drugs for Mifepristone →

Sponsor

Tobias Else

Who can join

18 and older, any sex, with Central Adrenal Insufficiency or Mifepristone. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Study Participants Recruited Primary · 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.

Group	Value	95% CI
Mifepristone	3

Number of Study Participants With Complete Study Data Captured Primary · 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).

Group	Value	95% CI
Mifepristone	3

Peak Cortisol Measured After Mifepristone Secondary · Day 2 (day after mifepristone administration)

Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).

Group	Value	95% CI
ITT Greater or Equal to 15 Max Cortisol	13.9	± 0.75

Absolute ACTH After Mifepristone Secondary · Day 2 (day after mifepristone administration)

ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.

Group	Value	95% CI
Greater or Equal to 15 Max Cortisol	18.5	± 1.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
   Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3