Glucocorticoid Receptor Antagonism in Subclinical Cushings - Full Text View

Purpose

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	Intervention	Phase
Subclinical Cushing's	Drug: Mifepristone	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings

Resource links provided by NLM:

MedlinePlus related topics: Steroids

Drug Information available for: Mifepristone

U.S. FDA Resources

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:

Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose homeostasis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	6
Study Start Date:	November 2008
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Use of mifepristone 200mg bd for 8 weeks

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721201

Locations


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

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators


Principal Investigator:	Dr John Newell Price	University of Sheffield

More Information

No publications provided by Sheffield Teaching Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Debono M, Chadarevian R, Eastell R, Ross RJ, Newell-Price J. Mifepristone reduces insulin resistance in patient volunteers with adrenal incidentalomas that secrete low levels of cortisol: a pilot study. PLoS One. 2013;8(4):e60984. doi: 10.1371/journal.pone.0060984. Epub 2013 Apr 5.


Responsible Party:	Dr John Newell-Price, University of Sheffield
ClinicalTrials.gov Identifier:	NCT00721201 History of Changes
Other Study ID Numbers:	STH14791
Study First Received:	July 21, 2008
Last Updated:	May 26, 2011
Health Authority:	United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:


subclinical Cushing's

Additional relevant MeSH terms:


Glucocorticoids Mifepristone Abortifacient Agents Abortifacient Agents, Steroidal Contraceptive Agents Contraceptive Agents, Female Contraceptives, Oral Contraceptives, Oral, Synthetic Contraceptives, Postcoital Contraceptives, Postcoital, Synthetic	Hormone Antagonists Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015