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Glucocorticoid Receptor Antagonism in Subclinical Cushings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00721201
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
HRA Pharma
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust

Study Description
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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

Condition or disease Intervention/treatment Phase
Subclinical Cushing's Drug: Mifepristone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings
Study Start Date : November 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Intervention Details:
  • Drug: Mifepristone
    Use of mifepristone 200mg bd for 8 weeks

Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Glucose homeostasis [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721201


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
HRA Pharma
Investigators
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Principal Investigator: Dr John Newell Price University of Sheffield
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr John Newell-Price, University of Sheffield
ClinicalTrials.gov Identifier: NCT00721201    
Other Study ID Numbers: STH14791
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
subclinical Cushing's
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
 Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents