Authorised Phase III and phase IV (Integrated) Primary adrenal insufficiency (PAI)

The CORTAD study

EU CTIS ID: 2024-512888-31-00

What this study is testing

Differences in health-related quality of life (HRQoL) scores in patients receiving Plenadren and conventional Cortisone at time of diagnosis and 1, 6, and 12 months.

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.