Ongoing Clinical Trials for Primary Adrenal Insufficiency
Currently, there are 2 ongoing clinical trials investigating treatments for Primary Adrenal Insufficiency, a condition where the adrenal glands do not produce enough hormones. These trials are taking place in Norway and Spain, testing different formulations of hormone replacement therapy to improve patient quality of life and treatment acceptance.
Clinical trial locations
- Norway
- Spain
Study on Quality of Life in Patients Aged 16-80 with Primary Adrenal Insufficiency Using Hydrocortisone (Plenadren) and Cortisone
This clinical trial, taking place in Norway, is comparing two different hormone replacement treatments to determine which offers better quality of life for patients with newly diagnosed Primary Adrenal Insufficiency.
Main inclusion criteria: Participants must be between 16 and 80 years old with a confirmed diagnosis of Primary Adrenal Insufficiency. They should have been on glucocorticoid replacement therapy for less than 31 days, meaning they are newly diagnosed. Women who can become pregnant must have a negative pregnancy test at screening. All participants must be able to understand the study and provide informed consent.
Main exclusion criteria: Patients who do not have Primary Adrenal Insufficiency cannot participate. Those outside the specified age range or who belong to vulnerable populations requiring special protection are also excluded.
Focus and goal: The study aims to investigate differences in health-related quality of life between patients receiving two different hormone replacement medications. Participants will be assessed at the time of diagnosis and then at 1, 6, and 12 months. Throughout the trial, researchers will monitor various health indicators including blood pressure, body weight, cholesterol levels, hormone levels, sleep patterns, and cognitive function. The study will also track any adverse events to ensure patient safety. The trial is expected to conclude by February 2027.
Investigational drugs: The trial compares Plenadren, a 20 mg modified-release hydrocortisone tablet that provides a controlled release to maintain stable hormone levels throughout the day, with Cortisone, a 25 mg conventional cortisone tablet that is converted to hydrocortisone in the liver. Both medications aim to supplement the hormones that the adrenal glands are not producing sufficiently.
Study on the Tolerability and Acceptance of Oral Hydrocortisone for Children with Adrenal Hyperplasia or Adrenal Insufficiency
This clinical trial, conducted in Spain, focuses on evaluating how well children with hormone-related conditions tolerate and accept different formulations of hydrocortisone medication.
Main inclusion criteria: Participants must be outpatients between 6 and 17 years old who do not have swallowing problems. They must have a diagnosis of adrenal hyperplasia, isolated Primary Adrenal Insufficiency, or panhypopituitarism. A parent or guardian must sign an informed consent document agreeing to the child’s participation.
Main exclusion criteria: While the trial includes children with adrenal hyperplasia and Primary Adrenal Insufficiency, patients with secondary or tertiary adrenal insufficiency resulting from pituitary or hypothalamus problems are excluded from this particular study.
Focus and goal: The main objective is to assess the sensory acceptability of two different hydrocortisone formulations prepared by the hospital pharmacy. Researchers want to understand how children perceive the taste, texture, and overall experience of taking each medication. This information will help determine which formulation is more suitable for pediatric patients, ensuring the treatment is both effective and easy for children to take. The trial is expected to run from January 2025 to January 2026.
Investigational drugs: Two different oral formulations of hydrocortisone are being tested. Hydrocortisone is a corticosteroid medication that mimics the action of cortisol, a hormone naturally produced by the adrenal glands. It helps regulate various bodily functions and is used to replace hormones when the body does not produce enough.
Summary
The two ongoing clinical trials for Primary Adrenal Insufficiency reflect different aspects of treatment optimization. The Norwegian study focuses on adult and adolescent patients, comparing quality of life outcomes between two different hormone replacement options over a 12-month period. The Spanish trial takes a different approach, concentrating on pediatric patients and the practical aspects of medication administration, specifically how acceptable different formulations are for children.
Both trials use hydrocortisone-based treatments, which remains the cornerstone of hormone replacement therapy for this condition. The geographical distribution shows research activity in different European countries, with each trial addressing distinct patient populations and research questions. These studies aim to provide valuable insights that could help healthcare providers tailor treatments more effectively to individual patient needs, whether that involves selecting the most beneficial medication for quality of life or ensuring that children can easily take their prescribed medication.
