Subclinical Cushing's
Conditions
Keywords
subclinical Cushing's
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
Interventions
DRUGMifepristone
Use of mifepristone 200mg bd for 8 weeks
Sponsors
HRA Pharma
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Glucose homeostasis | 8 weeks |
Countries
United Kingdom
Outcome results
None listed