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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450930

Acronym

PHYSCA

Enrollment

Registered

2011-10-13

Start date

2011-11-30

Completion date

2012-07-31

Last updated

2012-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Adrenal Insufficiency

Keywords

Adrenal insufficiency, Addison's disease

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 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.

Interventions

DRUGHydrocortisone intramuscular first

Hydrocortisone intramuscular first

DRUGHydrocortisone subcutaneously first

Hydrocortisone subcutaneously first

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence Study	4 hours	pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)

Secondary

Measure	Time frame	Description
safety	3 days	number of adverse events after subcutaneous administration of hydrocortisone

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026