DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Addison Disease; Adrenal Hyperplasia Congenital

Intervention: Solu-Cortef (Drug); Cortef (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Haukeland University Hospital

Official(s) and/or principal investigator(s):
Katerina Simunkova, MD, PhD, Principal Investigator, Affiliation: Universtity of Bergen
Kristian Løvås, MD, PhD, Study Director, Affiliation: Helse Bergen

Overall contact:
Kristian Løvås, MD, PhD, Phone: 55973075, Email: kristian.lovas@helse-bergen.no


The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

Clinical Details

Official title: Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum cortisol -24 hours curve

Secondary outcome:

Salivary cortisol - 24 hours curve

24 h urine cortisol and metabolites

levels of corticotropic hormone

24 hours curve of tissue cortisol

gene expression

Detailed description: The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) and congenital adrenal hyperplasia renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach does not enable to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of glucocorticoids leads to abnormal gene transcription and causes sides effect of glucocorticoids treatment and long standing complications Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, which can mimic not only the normal diurnal cortisol rhythm, but potentially also the ultradian cadence. This is a pilot trial with an open cross-over design of 3 x minimum 2 weeks in 10 patients comparing the effects of tablet treatment versus continuous subcutaneous hydrocortisone infusion versus ultradian subcutaneous hydrocortisone infusion on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. clinical diagnosis of primary adrenal insufficiency 2. Written informed consent Exclusion Criteria:. 1. Diabetes mellitus 2. Severe cardiovascular disease 3. Active malignant disease 4. Pregnancy or breast feeding 5. treatment with interfering drugs 6. Intake of grapefruit juice

Locations and Contacts

Kristian Løvås, MD, PhD, Phone: 55973075, Email: kristian.lovas@helse-bergen.no

University Hospital Helse Bergen, Bergen 5021, Norway; Recruiting
Katerina Simunkova, MD, PhD, Phone: 41079948, Email: katerina.simunkova@k2.uib.no
Kristian Løvås, MD, PhD, Phone: 55973075, Email: kristian.lovas@helse-bergen.no
Kristian Løvås, MD, PhD, Sub-Investigator
Katerina Simunkova, MD, PhD, Principal Investigator
Additional Information

Related publications:

Lightman SL, Conway-Campbell BL. The crucial role of pulsatile activity of the HPA axis for continuous dynamic equilibration. Nat Rev Neurosci. 2010 Oct;11(10):710-8. doi: 10.1038/nrn2914. Epub 2010 Sep 15.

Løvås K, Husebye ES. Continuous subcutaneous hydrocortisone infusion in Addison's disease. Eur J Endocrinol. 2007 Jul;157(1):109-12. Erratum in: Eur J Endocrinol. 2008 Jun;158(6):939. Dosage error in article text.

Lightman SL, Windle RJ, Julian MD, Harbuz MS, Shanks N, Wood SA, Kershaw YM, Ingram CD. Significance of pulsatility in the HPA axis. Novartis Found Symp. 2000;227:244-57; discussion 257-60. Review.

Starting date: August 2014
Last updated: March 27, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017