Not recruitingRare disease

Study on Quality of Life in Patients Aged 16-80 with Primary Adrenal Insufficiency Using Hydrocortisone (Plenadren) and Cortisone

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Primary Adrenal Insufficiency (PAI). This is a disorder where the adrenal glands do not produce enough hormones, which are crucial for various bodily functions. The study will compare two treatments: Plenadren 20 mg modified-release tablets and Cortison 25 mg tablets. Both medications are forms of hormone replacement therapy, with Plenadren containing hydrocortisone and Cortison containing cortisone. These treatments are designed to help manage the symptoms of PAI by supplementing the hormones that the adrenal glands are not producing sufficiently.

The purpose of this study is to investigate the differences in health-related quality of life for patients receiving these treatments. Participants in the study will be newly diagnosed with PAI and will be between the ages of 16 and 80. The study will follow participants from the time of diagnosis and then at 1, 6, and 12 months to assess how each treatment affects their quality of life. This will help determine which treatment might offer better outcomes for patients in terms of their daily well-being and overall health.

Throughout the study, various health indicators will be monitored, including blood pressure, body weight, and cholesterol levels, among others. Additionally, the study will look at hormone levels, sleep patterns, and cognitive function to provide a comprehensive view of how each treatment impacts the body. The study will also track any adverse events or symptoms related to adrenal crises to ensure patient safety. The trial is expected to conclude by February 2027.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 16 and 80 years, a recent diagnosis of primary adrenal insufficiency, and treatment with glucocorticoid replacement therapy for less than 31 days.
Women of childbearing potential must have a negative pregnancy test at the time of screening.
Step 2
Medication assignment
Participants are randomly assigned to receive either Plenadren or Cortison.
Plenadren is administered as a 20 mg modified-release tablet taken orally.
Cortison is administered as a 25 mg tablet taken orally.
Step 3
Treatment period
The treatment period involves regular administration of the assigned medication. Participants will take their medication as prescribed, with the frequency and dosage determined by the study protocol.
The study aims to observe differences in health-related quality of life scores at the time of diagnosis and at 1, 6, and 12 months.
Step 4
Monitoring and assessments
Throughout the study, various health parameters are monitored, including blood pressure, body weight, waist circumference, and body mass index.
Additional assessments include cholesterol levels, glucose, insulin, hair cortisol levels, and sleep patterns.
Cognitive testing and biomarkers for brain plasticity are also evaluated.
Step 5
Final evaluation
At the end of the study, a final evaluation is conducted to assess the overall impact of the treatment on health-related quality of life and other health parameters.
The study is estimated to conclude by February 28, 2027.

Who can join the trial?

5 criteria

Age between 16 and 80 years.
Must have a confirmed diagnosis of Primary Adrenal Insufficiency (PAI), which is a condition where the adrenal glands do not produce enough hormones.
Must be recently diagnosed and have been on glucocorticoid replacement therapy for less than 31 days. This therapy involves taking medication to replace hormones that the adrenal glands are not making.
Women who can have children must have a negative pregnancy test at the time of screening.
Must be able to understand the study and sign a consent form agreeing to participate.

Who cannot join the trial?

3 criteria

Patients who do not have Primary adrenal insufficiency (PAI). This is a condition where the adrenal glands do not produce enough hormones.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Sykehuset I Vestfold HF
Responsive
Tonsberg, Norway
Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Plenadren
is a medication used in this study to treat individuals with primary adrenal insufficiency. It is designed to help manage the symptoms of this condition by providing a steady release of hormones that the adrenal glands typically produce. The goal is to improve the quality of life for patients by maintaining more consistent hormone levels throughout the day.
Cortisone
is another treatment option being studied for primary adrenal insufficiency. It is a conventional therapy that helps replace the hormones that the adrenal glands are unable to produce. This medication aims to alleviate symptoms and improve the overall well-being of patients by supplementing their hormone levels.

What is already known about the treatment

Plenadren
Plenadren is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its impact on quality of life in patients with primary adrenal insufficiency. The main therapeutic indication for Plenadren is to manage adrenal insufficiency by providing a controlled release of hydrocortisone, which helps maintain stable cortisol levels in the body. At the molecular level, it works by mimicking the natural rhythm of cortisol production, which is crucial for various bodily functions. Plenadren is classified as a glucocorticoid medication.
Cortisone
Cortisone is typically administered orally in tablet form. It is a well-established medication used to treat primary adrenal insufficiency, among other conditions. The primary therapeutic indication is to replace cortisol in individuals whose bodies do not produce enough of this hormone. Cortisone is converted into hydrocortisone in the liver, which then exerts its effects by binding to glucocorticoid receptors, influencing various metabolic and immune processes. It is classified as a corticosteroid.

Investigated diseases

Primary Adrenal Insufficiency – This condition occurs when the adrenal glands do not produce enough of certain hormones, particularly cortisol and sometimes aldosterone. It can lead to symptoms such as fatigue, muscle weakness, and weight loss. Patients may also experience low blood pressure, salt cravings, and darkening of the skin. The disease progresses as the adrenal glands continue to underproduce hormones, which can affect various bodily functions. Over time, individuals may notice an increase in symptoms, especially during times of stress or illness. Regular monitoring and management are essential to maintain hormone balance and overall health.