Glucocorticoid Receptor Antagonism in Subclinical Cushings

NHS Foundation Trust

Status and phase: Completed; Phase 2; Phase 1

Conditions: Subclinical Cushing's

Treatments: Drug: Mifepristone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00721201

STH14791

Details and patient eligibility

About

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

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)