NCT01450930

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Bruno Allolio · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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 of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.

Conditions

• Primary Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Hydrocortisone intramuscular first	Hydrocortisone intramuscular first
DRUG	Hydrocortisone subcutaneously first	Hydrocortisone subcutaneously first

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-10-13
• Last updated: 2012-08-01

Locations

1 site across 1 country: Germany