Evaluation of the time to cortisol levels required in critical illness (>1000 nmol/l) and safety of hydrocortisone, after subcutaneous injection in patients with chronic primary adrenal insufficiency(Comparison s.c. vs. i.m.)

• Conditions: Adrenal insufficiency under chronic glucocorticoid replacement; MedDRA version: 14.0Level: PTClassification code 10001130Term: Addison's diseaseSystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.0Level: PTClassification code 10052381Term: Primary adrenal insufficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-002687-25-DE
• Lead Sponsor: niversity Hospital of Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-06
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

patients with chronic primary adrenal insufficiency due to autoimmune adrenalitis or bilateral adrenalectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diabetes mellitus, fever at time of investigation, oral contraception, pregnancy, breast feeding, renal failure, intolerance to the study drug or constituents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified