Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Mifepristone Clinical Trial

Official title:

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04588688
• Other study ID #: HUM00160641
• Status: Terminated
• Phase: Phase 2
• Start date: May 5, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Central Adrenal Insufficiency
• Mifepristone

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Tobias Else	Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Participants Recruited	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.	Up to 88 days
Primary	Number of Study Participants With Complete Study Data Captured	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).	30 days
Secondary	Peak Cortisol Measured After Mifepristone	Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).	Day 2 (day after mifepristone administration)
Secondary	Absolute ACTH After Mifepristone	ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.	Day 2 (day after mifepristone administration)