A registry-based, open-label, randomized study to investigate quality-of-life with Plenadren compared with Cortison in participants aged 16-80 with newly diagnosed primary adrenal insufficiency (CORTAD)

Helse Bergen HF0 个研究点目标入组 50 人开始时间: 2024年7月5日最近更新: 2024年8月21日

适应症

试验速览

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•Age 16-80 years, Established PAI according to the diagnostic criteria as specified above., Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 31 days prior to inclusion to secure treatment naivety., Women of childbearing potential (WOCBP) must have a negative pregnancy test performed at the time of screening., Participants must be capable of giving signed informed consent

•High dose glucocorticoid therapy for other disease during last three months prior to screening., Ongoing treatment for active malignant disease., Severe hepatic or renal disease., Sever psychiatric disease., Chronic abuse of alcohol or drug abuse., Current pregnancy, and if the participant plan to become pregnant during the 12 months of study participation., Known hypersensitivity to the active substance or any of the excipients., Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion.

发起方