Glucocorticoid Receptor Antagonism in Subclinical Cushings

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT00721201
• Date of registration: 21/07/2008
• Prospective Registration: Yes
• Primary sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Public title: Glucocorticoid Receptor Antagonism in Subclinical Cushings
• Scientific title: A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings
• Date of first enrolment: November 2008
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00721201
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Dr John Newell Price
• Affiliation: University of Sheffield

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients will be eligible for inclusion if: they are males and over 18, lack clinical
features classically associated with Cushing's syndrome; have evidence of excess
circulating cortisol

Exclusion Criteria:

- Evidence of local or systemic malignancy; overt Cushing's syndrome; severe
uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly
impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease
(liver enzymes = 3 x the institutional upper limit of normal range); significantly
impaired renal function (eGFR <30/min); uncontrolled severe active infection;
treatment with approved or experimental steroidogenesis inhibitors, adrenolytic
agents, within four weeks of admission; In women, known endometrial cancer, history of
endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled
or systemic glucocorticoids for existing disease; impaired mental capacity or markedly
abnormal psychiatric evaluation that precludes informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Subclinical Cushing's

Intervention(s)

Drug: Mifepristone

Primary Outcome(s)

Blood pressure [Time Frame: 8 weeks]

Secondary Outcome(s)

Glucose homeostasis [Time Frame: 8 weeks]

Secondary ID(s)

STH14791

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

HRA Pharma