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Clinical Trials/NCT00721201
NCT00721201
Completed
Phase 1

A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings

Sheffield Teaching Hospitals NHS Foundation Trust1 site in 1 country6 target enrollmentNovember 2008
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ConditionsSubclinical Cushing's
DrugsMifepristone

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Subclinical Cushing's
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
6
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
March 2010
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Blood pressure

Time Frame: 8 weeks

Secondary Outcomes

  • Glucose homeostasis(8 weeks)

Study Sites (1)

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