Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia
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ClinicalTrials.gov Identifier: NCT02096510 |
Recruitment Status : Unknown
Verified December 2016 by Haukeland University Hospital.
Recruitment status was: Recruiting
First Posted : March 26, 2014
Last Update Posted : December 21, 2016
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Condition or disease | Intervention/treatment | Phase |
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Addison Disease Adrenal Hyperplasia Congenital | Drug: Solu-Cortef Drug: Cortef | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: continuous subcutaneous hydrocortisone
continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate
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Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone Drug: Cortef tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets |
Active Comparator: cortef tablets
the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.
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Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone Drug: Cortef tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets |
Experimental: ultradian subcutaneous hydrocortisone
ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate
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Drug: Solu-Cortef
administration by pump for minimum 2 weeks
Other Name: hydrocortisone Drug: Cortef tablet treatment 2 ro 3 times per day for 14 days
Other Name: hydrocortisone tablets |
- Serum cortisol -24 hours curve [ Time Frame: 24 hours ]admission to hospital for 24 hours
- Salivary cortisol - 24 hours curve [ Time Frame: 24 hours ]admission to the hospital for 25 hours
- 24 h urine cortisol and metabolites [ Time Frame: 24 hours ]urine samples for 24 hours
- levels of corticotropic hormone [ Time Frame: 24 hours ]blood samples
- 24 hours curve of tissue cortisol [ Time Frame: 24 hours ]The tissue effect of glucocorticoid replacement - 24 hours curve of tissue cortisol (microdialysis)
- gene expression [ Time Frame: 24 hours ]m RNA expression of genes

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- clinical diagnosis of primary adrenal insufficiency
- Written informed consent
Exclusion Criteria:.
- Diabetes mellitus
- Severe cardiovascular disease
- Active malignant disease
- Pregnancy or breast feeding
- treatment with interfering drugs
- Intake of grapefruit juice

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): NCT02096510
Contact: Kristian Løvås, MD, PhD | 55973075 | kristian.lovas@helse-bergen.no | |
Contact: Katerina Simunkova, MD, PhD | 41079948 | katerina.simunkova@k2.uib.no |
Norway | |
University Hospital Helse Bergen | Recruiting |
Bergen, Norway, 5021 | |
Contact: Katerina Simunkova, MD, PhD 41079948 katerina.simunkova@k2.uib.no | |
Contact: Kristian Løvås, MD, PhD 55973075 kristian.lovas@helse-bergen.no | |
Sub-Investigator: Kristian Løvås, MD, PhD | |
Principal Investigator: Katerina Simunkova, MD, PhD |
Principal Investigator: | Katerina Simunkova, MD, PhD | Universtity of Bergen | |
Study Director: | Kristian Løvås, MD, PhD | Helse Bergen |
Responsible Party: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT02096510 |
Other Study ID Numbers: |
2013/1738 |
First Posted: | March 26, 2014 Key Record Dates |
Last Update Posted: | December 21, 2016 |
Last Verified: | December 2016 |
Addison Disease Adrenal Hyperplasia Congenital |
Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Adrenocortical Hyperfunction Addison Disease Hyperplasia Pathologic Processes Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Genetic Diseases, Inborn Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors |
Metabolic Diseases Adrenal Gland Diseases Endocrine System Diseases Gonadal Disorders Adrenal Insufficiency Autoimmune Diseases Immune System Diseases Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Anti-Inflammatory Agents |