Not provided
Not provided
Not provided
Not provided
Not provided
low recruitment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Corcept Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Absolute ACTH After Mifepristone |
Not provided
Inclusion Criteria (1 of the following):
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tobias Else, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
The results from the insulin tolerance test (ITT) served to group the participants into two arms for analysis: high suspicion for adrenal sufficiency (maximum cortisol greater than or equal to 15 microg/dl) or high suspicion for adrenal insufficiency (maximum cortisol less than 15 microg/dl). The ITT serves as the gold standard and the cut-off of 15 microg/dl was used as a conservative cut-off in accordance with local experience with this test.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Greater or Equal to 15 Max Cortisol | Suspected adrenal sufficient by ITT. |
| BG001 | Less Than 15 Max Cortisol | Suspected adrenal insufficient by ITT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 88 days |
|
Day 2, Day 7, and Day 30
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mifepristone | 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tobias Else | University of Michigan | 734-936-1319 | telse@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2020 | Nov 7, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm. |
| Day 2 (day after mifepristone administration) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Peak cortisol measured after Insulin Tolerance Testing (ITT) | Peak cortisol measured in participants following ITT. | Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Data are not shared to preserve privacy. | Mean | Standard Deviation | micrograms per deciliter |
|
|
|
| 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). | Posted | Count of Participants | Participants | 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). | Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy. | Posted | Mean | Standard Deviation | micrograms per deciliter | 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. | Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy. | Posted | Mean | Standard Deviation | Picogram per milliliter | Day 2 (day after mifepristone administration) |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|