Glucocorticoid Receptor Antagonism in Subclinical Cushings
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ClinicalTrials.gov Identifier: NCT00721201 |
Recruitment Status :
Completed
First Posted : July 23, 2008
Last Update Posted : January 26, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subclinical Cushing's | Drug: Mifepristone | Phase 1 Phase 2 |
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 |

- Drug: Mifepristone
Use of mifepristone 200mg bd for 8 weeks
- Blood pressure [ Time Frame: 8 weeks ]
- Glucose homeostasis [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United Kingdom | |
Sheffield Teaching Hospitals NHS Foundation Trust | |
Sheffield, United Kingdom |
Principal Investigator: | Dr John Newell Price | University of Sheffield |
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 |
subclinical Cushing's |
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 |