Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Bruno Allolio12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Adrenal Insufficiency

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Bioequivalence Study

pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)

Time frame: 4 hours

Secondary Outcomes

safety

number of adverse events after subcutaneous administration of hydrocortisone

Time frame: 3 days