drugset
drugset / Trial / NCT06260462

Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency

NCT06260462 ↗

Phase 3 Completed 88 enrolled University of Palermo
RandomizedParallel-groupOpen-labelTreatment

Summary

The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period.

Timeline

Start
2012-01-01
Primary completion
2022-09-30
Completion
2023-12-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cortisone acetate Other / unclassified 10 mg Oral
Subject Cortisone acetate Other / unclassified 15 mg Oral
Subject Cortisone acetate Other / unclassified 20 mg Oral
Subject Cortisone acetate Other / unclassified 25 mg Oral
Subject Cortisone acetate Other / unclassified 37.5 mg Oral
Subject Cortisone acetate Other / unclassified 50 mg Oral
Subject Cortisone acetate Other / unclassified 62.5 mg Oral
Subject Hydrocortisone Other / unclassified 10 mg Oral
Subject Hydrocortisone Other / unclassified 15 mg Oral
Subject Hydrocortisone Other / unclassified 20 mg Oral
Subject Hydrocortisone Other / unclassified 25 mg Oral
Subject Hydrocortisone Other / unclassified 30 mg Oral
Subject Hydrocortisone Other / unclassified 37.5 mg Oral
Subject Hydrocortisone Other / unclassified 40 mg Oral
Subject Hydrocortisone Other / unclassified 50 mg Oral
Subject Hydrocortisone Other / unclassified 62.5 mg Oral

Indications

adrenocortical insufficiency