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

• Conditions: Addison`s disease; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-004189-33-NO
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified