In short
There is currently 1 ongoing clinical trial investigating treatment options for adrenal hyperplasia. This trial is evaluating the tolerability and acceptance of oral hydrocortisone formulations in children and adolescents with adrenal hyperplasia and related conditions affecting hormone production.
Clinical trial locations
Study on the Tolerability and Acceptance of Oral Hydrocortisone for Children with Adrenal Hyperplasia or Adrenal Insufficiency
This clinical trial is being conducted in Spain and focuses on evaluating how well children and teenagers tolerate and accept two different oral formulations of hydrocortisone. The study is designed for young patients with conditions that affect the body's ability to produce certain hormones, including adrenal hyperplasia, primary adrenal insufficiency, and panhypopituitarism.
Who can participate?
To be eligible for this study, patients must meet several criteria:
- Be outpatients (not requiring overnight hospital stays)
- Be between 6 and 17 years old
- Have no swallowing difficulties
- Have a confirmed diagnosis of adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism
- Have informed consent signed by a parent or guardian
Both boys and girls are welcome to participate in the trial.
Who cannot participate?
The trial excludes patients with certain forms of adrenal insufficiency. Specifically, those with secondary or tertiary adrenal insufficiency, where the problem originates from the pituitary gland or hypothalamus rather than the adrenal glands themselves, are not eligible. Additionally, patients who have difficulty swallowing cannot join the study.
What is the focus of the trial?
The main goal of this study is to assess the sensory acceptability of two hydrocortisone formulations prepared by the Hospital Pharmacy Service. Researchers want to understand how children experience these medications in terms of taste, texture, and overall ease of use. This information is important because medications that are easier and more pleasant for children to take can lead to better treatment outcomes.
The trial began recruiting patients in January 2025 and is expected to continue until January 2026. Throughout the study period, participants will be carefully monitored to ensure their safety while researchers gather information about their responses to the medication.
What medication is being tested?
The investigational drug in this trial is hydrocortisone, a type of steroid medication used to replace hormones that the body is not producing in sufficient amounts. Hydrocortisone mimics the action of cortisol, a hormone naturally produced by the adrenal glands that helps regulate various important bodily functions. This medication belongs to a class of drugs called corticosteroids, which help reduce inflammation and support the body's stress response. Two different oral formulations of hydrocortisone will be compared to determine which one is better suited for children in terms of tolerability and acceptance.
Summary
Currently, there is one ongoing clinical trial for adrenal hyperplasia, located in Spain. This trial focuses specifically on the pediatric population, studying children and adolescents aged 6 to 17 years. The study addresses an important practical aspect of treatment: how well young patients tolerate and accept their medication. By comparing two different oral hydrocortisone formulations, researchers aim to identify which option is most suitable for children, potentially improving treatment adherence and quality of life for young patients with adrenal hyperplasia and related conditions. The trial is expected to provide valuable insights into optimizing hydrocortisone therapy for the pediatric population during 2025-2026.
