Clinical trial: A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT) (NCT03210545)

Eligibility criteria:
Inclusion Criteria:

          1. Males and females at ages 20-65 years

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

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

          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 to
             study entry

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

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

        Exclusion Criteria:

          1. Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
             hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere
             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 with
             the study drugs kinetics, including therapies affecting gastro intestinal emptying or
             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 of
             choice

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

         11. Any additional underlying condition that needs treatment with intramuscular or
             intra-articular steroid injections during the trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months.  She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs.  Physical examination shows a generalized increase in pigmentation of the skin.  Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease)

Patient description (patient's own words): I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy.

Does the patient match the trial criteria? Entailment