Phase
Condition
Female Hormonal Deficiencies/abnormalities
Treatment
Betamethasone
Clinical Study ID
Ages 20-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females at ages 20-65 years
Previously diagnosed (e.g. more than 12 months ago) with primary adrenalinsufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
A stable daily glucocorticoid replacement dose for at least 3 months prior to studyentry
An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
If needed, a stable fludrocortisone replacement dose for at least 3 months prior tostudy entry
Body mass index (BMI) of 20-35 kg/m2
Ability to comply to the protocol procedures and having signed informed consent toparticipate in the study
Exclusion
Exclusion Criteria:
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
Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
Pregnant or lactating women
Diabetes Mellitus
Systemic infections
Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
Any medication with agents which in the investigators judgement might interfere withthe study drugs kinetics, including therapies affecting gastro intestinal emptyingor motility
Alcohol/drug abuse or any other condition associated with poor patient compliance,including expected non-cooperation, as judged by the investigator
Hypersensitivity to the active substance or any excipients used in the study drug ofchoice
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
Any additional underlying condition that needs treatment with intramuscular orintra-articular steroid injections during the trial
Study Design
Connect with a study center
Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital
Gothenburg, 413 45
SwedenSite Not Available
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