A trial comparing continuous subcutaneous hydrocortisone therapy with pulsatile subcutaneous hydrocortisone therapy in patients with Addison`s disease

ULTRADIAN SUBCUTANEOUS HYDROCORTISONE (USHI) INFUSION IN ADDISON’S DISEASE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004189-33-NO

Enrollment

Registered

2013-10-30

Start date

2013-11-28

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Addison`s disease

Interventions

Trade Name: Solu-Cortef Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Cortef 5 mg Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with verified Addison`s disease , age 18-65, will be included. In case of other concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period. The patient will have to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria are cardiovascular disease, active malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns war, estrogens).The patients should not take grapefruit juice the last two weeks before or during the study period.

Design outcomes

Primary

Measure	Time frame
Main Objective: The conventional glucocorticoid replacement therapy in AD renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach is enabling to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of GC leads to abnormal gene transcription and causes sides effect of GC treatment and long standing complications. The aim of this study is to compare the effects of circadian with combined circadian and ultradian continuous subcutaneous hydrocortisone infusion (CSHI) on steroid metabolism and tissue responses to therapy. ;Secondary Objective: the effects of CSHI versus USHI on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.;Primary end point(s): We aim to evaluate the effects of USHI (ultradian variation) compared to CSHI (circadian variation) on steroid metabolism to explore whether the USHI regimen is able to restore the ultradian rhythmicity. Primary endpoints: Treatment effects on levels of glucocorticoids and metabolites in serum •Serum cortisol -24 hours curve ;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment in each period (CSHI and USHI)	—

Measure

Time frame

Main Objective: The conventional glucocorticoid replacement therapy in AD renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. This therapeutical approach is enabling to restore physiological circadian and ultradian rhythm of glucocorticoids. Current studies conclude that constant or unphysiological administration of GC leads to abnormal gene transcription and causes sides effect of GC treatment and long standing complications. The aim of this study is to compare the effects of circadian with combined circadian and ultradian continuous subcutaneous hydrocortisone infusion (CSHI) on steroid metabolism and tissue responses to therapy. ;Secondary Objective: the effects of CSHI versus USHI on serum, salivary, tissue hormonal response and glucocorticoid related gene expression.;Primary end point(s): We aim to evaluate the effects of USHI (ultradian variation) compared to CSHI (circadian variation) on steroid metabolism to explore whether the USHI regimen is able to restore the ultradian rhythmicity. Primary endpoints: Treatment effects on levels of glucocorticoids and metabolites in serum •Serum cortisol -24 hours curve ;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment in each period (CSHI and USHI)

—

Secondary

Measure	Time frame
Secondary end point(s): • The tissue effect of glucocorticoid replacement – 24 hours curve of tissue cortisol (microdialysis) • m RNA expression of genes (microdialysis) • ACTH levels • Salivary cortisol - 24 hours curve • 24 h urine cortisol and metabolites ;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment in each period (CSHI and USHI)	—

Countries

Norway

Contacts

Public ContactKristian Løvås

Haukeland University Hospital

kral@helse-bergen.no4755977996

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026