Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency (PHYSCA)
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ClinicalTrials.gov Identifier: NCT01450930 |
Recruitment Status
:
Completed
First Posted
: October 13, 2011
Last Update Posted
: August 1, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Adrenal Insufficiency | Drug: Hydrocortisone intramuscular first Drug: Hydrocortisone subcutaneously first | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Hydrocortisone subcutaneously first
Hydrocortisone subcutaneously first
|
Drug: Hydrocortisone subcutaneously first
Hydrocortisone subcutaneously first
Other Name: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
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Active Comparator: Hydrocortisone intramuscular first
Hydrocortisone intramuscular first
|
Drug: Hydrocortisone intramuscular first
Hydrocortisone intramuscular first
Other Name: 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
|
- Bioequivalence Study [ Time Frame: 4 hours ]pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)
- safety [ Time Frame: 3 days ]number of adverse events after subcutaneous administration of hydrocortisone

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450930
Germany | |
Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg | |
Wuerzburg, Germany, 97080 |
Principal Investigator: | Stefanie Hahner, MD | University Hospital Wuerzburg, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bruno Allolio, MD, Professor of Medicine, head of the Dept. of Endocrinology and Diabetology, University of Wuerzburg, University of Wuerzburg |
ClinicalTrials.gov Identifier: | NCT01450930 History of Changes |
Other Study ID Numbers: |
PHYSCA-1 2011-002687-25 ( EudraCT Number ) |
First Posted: | October 13, 2011 Key Record Dates |
Last Update Posted: | August 1, 2012 |
Last Verified: | July 2012 |
Keywords provided by Bruno Allolio, University of Wuerzburg:
Adrenal insufficiency Addison's disease |
Additional relevant MeSH terms:
Addison Disease Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Hydrocortisone Epinephrine Racepinephrine Epinephryl borate Anti-Inflammatory Agents Adrenergic alpha-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |