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

Phase 1

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

• Registration Number: EUCTR2007-007604-15-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-21
• Study Completion: 2010-05-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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? ;<br> Primary end point(s): the primary outcome measures are:<br> 1) ambulatory and resting blood pressure are 8 weeks<br> 2) 2-hour glucose tolerance at 8 weeks<br>