Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
Recruiting
Phase 4
Interventional Study
Congenital Adrenal Hyperplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Federico II University · Other
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About This Trial
This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of life, reproductive, sexual and psychological functions and treatment compliance in patients affected by congenital adrenal hyperplasia due to 21 O…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* males and females aged \>18 years;
* established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency;
* stably treated with conventional glucocorticoids, available to change their regimen according to random allocation
* writte…
Contacts