Central Adrenal Insufficiency, Mifepristone
Conditions
Keywords
Insulin Tolerance Test
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.
Interventions
DRUGMifepristone
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.
Sponsors
Corcept Therapeutics
Tobias Else
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Recruited | 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. |
| Number of Study Participants With Complete Study Data Captured | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Cortisol Measured After Mifepristone | Day 2 (day after mifepristone administration) | Serum cortisol was collected the day after mifepristone administration and insulin tolerance test insulin tolerance test (ITT). |
| Absolute ACTH After Mifepristone | Day 2 (day after mifepristone administration) | ACTH level 8:00 am (Day 2) following administration of mifepristone the night before at 10:00 pm. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Greater or Equal to 15 Max Cortisol Suspected adrenal sufficient by ITT. | 2 |
| Less Than 15 Max Cortisol Suspected adrenal insufficient by ITT. | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Less Than 15 Max Cortisol | Greater or Equal to 15 Max Cortisol | Total |
|---|---|---|---|
| Age, Customized 50 - 59 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized 60 - 69 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Peak cortisol measured after Insulin Tolerance Testing (ITT) | — | 24.4 micrograms per deciliter STANDARD_DEVIATION 3.15 | 24.4 micrograms per deciliter STANDARD_DEVIATION 3.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: Up to 88 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Study Participants Recruited | 3 Participants |
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).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone | Number of Study Participants With Complete Study Data Captured | 3 Participants |
Secondary
Absolute ACTH After Mifepristone
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)
Population: Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone | Absolute ACTH After Mifepristone | 18.5 Picogram per milliliter | Standard Deviation 1.5 |
Secondary
Peak Cortisol Measured After Mifepristone
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)
Population: Only 1 participant was in the ITT Less Than 15 Max Cortisol arm. Results are not shared to preserve privacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone | Peak Cortisol Measured After Mifepristone | 13.9 micrograms per deciliter | Standard Deviation 0.75 |