Status:
COMPLETED
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
Lead Sponsor:
Bruno Allolio
Conditions:
Primary Adrenal Insufficiency
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
- age ≥ 18 years,
- Patient´s written informed consent,
- Ability to comply with the protocol procedures
- Exclusion criteria
- Diabetes mellitus,
- Infectious disease with fever at time of investigation,
- Known intolerance to the study drug or constituents oft he study drug,
- Oral contraception,
- Known pregnancy or breast feeding,
- Renal failure (creatinine \> 2.5 ULN)
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01450930
Start Date
November 1 2011
End Date
July 1 2012
Last Update
August 1 2012
Active Locations (1)
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1
Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg
Würzburg, Germany, 97080