NCT04588688

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Tobias Else · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Adrenal Insufficiency
• Mifepristone

Interventions

Type	Name	Description
DRUG	Mifepristone	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.

Timeline

• Start date: 2021-05-05
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2020-10-19
• Last updated: 2023-06-12
• Results posted: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study