A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007604-15-GB

Enrollment

Registered

2008-08-21

Start date

2009-03-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sub Clinical Cushing's Syndrome MedDRA version: 9.1 Level: PT Classification code 10011652 Term: Cushing's syndrome

Interventions

Trade Name: mifedren Product Name: HRA052015 (mifepristone) Product Code: HRA052015 Pharmaceutical Form: Tablet INN or Proposed INN: MIF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - male and over 18 years old or postmenopausal women - Patients have adrenal incidentaloma with benign characteristics as assessed on CT or MRI - Patients lack clinical features classically associated with Cushing's Syndrome - Patients have evidence of excess cortisol as shown by lack of supression of serum cortisol using standard routine tests - Patients are on stable antihypertensive and diabetic medication for two months prior to study entry Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria include: - evidence of local or systemic malignancy - overt Cushing's Syndrome - servere uncontrolled diabetes mellitus or hypertension - pregnancy - clinically significantly impaired cardiovascular function, severe liver disease, significantly impaired renal function - uncontrolled severe active infection - treatment with approved or experimental drugs which work on the adrenal glands - in women a known history of uterine problems - a requirement for steroids for existing disease - impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The principle research question is, does mifepristone, a glucocorticoid (steroid) receptor antagonist, improve cardiovascular and biochemical profiles in patients with sub-clinical Cushing's Syndrome, a condition where an abnormally high level of steroids (cortisol) are being produced? ;Secondary Objective: Are there biochemical markers which predict or explain the response observed with mifepristone in patients with sub-clinical Cushing's Syndrome? ; Primary end point(s): the primary outcome measures are: 1) ambulatory and resting blood pressure are 8 weeks 2) 2-hour glucose tolerance at 8 weeks	—

Measure

Time frame

Main Objective: The principle research question is, does mifepristone, a glucocorticoid (steroid) receptor antagonist, improve cardiovascular and biochemical profiles in patients with sub-clinical Cushing's Syndrome, a condition where an abnormally high level of steroids (cortisol) are being produced? ;Secondary Objective: Are there biochemical markers which predict or explain the response observed with mifepristone in patients with sub-clinical Cushing's Syndrome? ; Primary end point(s): the primary outcome measures are: 1) ambulatory and resting blood pressure are 8 weeks 2) 2-hour glucose tolerance at 8 weeks

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026