Status:
UNKNOWN
Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
Lead Sponsor:
Ulla Feldt-Rasmussen
Conditions:
Adrenal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Despite optimized hydrocortisone replacement regimes, many patients with adrenal insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients report high fatigue levels ...
Detailed Description
The study is conducted as an open-label, single-arm, two-period, crossover pilot trial. Includible patients are observed for 5 weeks on their usual treatment (twice or thrice daily hydrocortisone). As...
Eligibility Criteria
Inclusion
- Diagnosed with adrenal insufficiency due to hypopituitarism
- In steady twice or thrice daily (10-40 mg) hydrocortisone replacement treatment
- Written informed consent
- For women: Use of reliable methods of contraception in clinical trials in accordance with the definition by the Danish Health and Medicines Authority; intrauterine devices or hormonal methods (oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
Exclusion
- Pregnancy
- Breast feeding
- Acromegaly
- Cushing's Disease
- Diabetes Mellitus
- Other major confounding disease
- Known or expected hypersensitivity to any of the excipients
- Lack of compliance (attendance and medication)
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02282150
Start Date
October 1 2016
End Date
December 1 2017
Last Update
February 23 2017
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