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)

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512888-31-00

Enrollment

Registered

2024-08-07

Start date

2023-08-03

Completion date

Unknown

Last updated

2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary adrenal insufficiency (PAI)

Brief summary

HRQoL score.

Detailed description

Blood pressure, body weight, waist circumference, body mass index, cholesterols, glucose, insulin, HOMA index., Hair cortisol level, Salivary cortisol day curves, 24 h urine cortisol and metabolites., Sleep diary, actigraphy, sleep radar., Cognitive testing and biomarker for brain plasticity (BDNF) in serum., Bone mineral density, body composition and bone markers, Adverse events, Serious adverse events, Adrenal crisis symptoms and treatment.

Interventions

DRUGPlenadren 20 mg modified-release tablets

DRUGCortison 25 mg tabletter

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
HRQoL score.	—

Secondary

Measure	Time frame
Blood pressure, body weight, waist circumference, body mass index, cholesterols, glucose, insulin, HOMA index., Hair cortisol level, Salivary cortisol day curves, 24 h urine cortisol and metabolites., Sleep diary, actigraphy, sleep radar., Cognitive testing and biomarker for brain plasticity (BDNF) in serum., Bone mineral density, body composition and bone markers, Adverse events, Serious adverse events, Adrenal crisis symptoms and treatment.	—

Measure

Time frame

—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026