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Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Primary Purpose

Central Adrenal Insufficiency, Mifepristone

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Sponsored by
Tobias Else
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Adrenal Insufficiency focused on measuring Insulin Tolerance Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mifepristone

Arm 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Peak Cortisol Measured After Mifepristone
Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).
Absolute ACTH After Mifepristone
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.

Full Information

First Posted
October 9, 2020
Last Updated
May 19, 2023
Sponsor
Tobias Else
Collaborators
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04588688
Brief Title
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Official Title
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tobias Else
Collaborators
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Adrenal Insufficiency, Mifepristone
Keywords
Insulin Tolerance Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
KORLYM®, C1073, RU486
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Study Participants Recruited
Description
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.
Time Frame
Up to 88 days
Title
Number of Study Participants With Complete Study Data Captured
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Peak Cortisol Measured After Mifepristone
Description
Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT).
Time Frame
Day 2 (day after mifepristone administration)
Title
Absolute ACTH After Mifepristone
Description
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm.
Time Frame
Day 2 (day after mifepristone administration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Else, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

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