Glucocorticoid Receptor Antagonism in Subclinical Cushings

January 22, 2021 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose homeostasis
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

HRA Pharma

Investigators

  • Principal Investigator: Dr John Newell Price, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (ESTIMATE)

July 23, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH14791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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