A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

Last updated: April 22, 2025
Sponsor: Göteborg University
Overall Status: Completed

Phase

4

Condition

Female Hormonal Deficiencies/abnormalities

Treatment

Betamethasone

Clinical Study ID

NCT03210545
DOSCORT
2016-004078-16
  • Ages 20-65
  • All Genders

Study Summary

DOSCORT is a 2-dose, cross-over study primarily aiming to identify and validate novel biological markers (biomarkers) of glucocorticoid effect in the human body. Patients with Addison´s disease, primary adrenal insufficiency, with life-long glucocorticoid replacement therapy will undergo 2 treatment periods where their usual hydrocortisone treatment will be replaced with betamethasone in physiological and supra physiological doses. Blood, saliva, urine, health related Quality-of-life self-assessment forms, measurements of physical activity and sleep quality will be collected from both treatment periods.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females at ages 20-65 years

  2. Previously diagnosed (e.g. more than 12 months ago) with primary adrenalinsufficiency due to autoimmune adrenalitis, i.e. Addison´s disease

  3. A stable daily glucocorticoid replacement dose for at least 3 months prior to studyentry

  4. An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose

  5. If needed, a stable fludrocortisone replacement dose for at least 3 months prior tostudy entry

  6. Body mass index (BMI) of 20-35 kg/m2

  7. Ability to comply to the protocol procedures and having signed informed consent toparticipate in the study

Exclusion

Exclusion Criteria:

  1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,hepaticobiliary/ pancreatic disease which in the investigators judgement mayinterfere with the study assessment of completion of the study

  2. Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L

  3. Pregnant or lactating women

  4. Diabetes Mellitus

  5. Systemic infections

  6. Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks

  7. Any medication with agents which in the investigators judgement might interfere withthe study drugs kinetics, including therapies affecting gastro intestinal emptyingor motility

  8. Alcohol/drug abuse or any other condition associated with poor patient compliance,including expected non-cooperation, as judged by the investigator

  9. Hypersensitivity to the active substance or any excipients used in the study drug ofchoice

  10. Any additional underlying disease that may need regular or periodic pharmacologicaltreatment with glucocorticoids during the trail, such as asthma, skin- or eyeconditions treated with inhaled or topical glucocorticoids

  11. Any additional underlying condition that needs treatment with intramuscular orintra-articular steroid injections during the trial

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Betamethasone
Phase: 4
Study Start date:
March 02, 2021
Estimated Completion Date:
February 16, 2022

Connect with a study center

  • Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital

    Gothenburg, 413 45
    Sweden

    Site Not Available

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