Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Once-Daily pill could simplify CAH treatment

NCT ID NCT03760835

Disease control Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a once-daily dual-release hydrocortisone pill (Plenadren) works better than standard multiple-dose glucocorticoids for adults with congenital adrenal hyperplasia. The trial will enroll 150 adults and measure changes in cholesterol, blood sugar, weight, blood pressure, and quality of life. The goal is to see if the simpler dosing schedule improves health outcomes and daily living.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dual-release hydrocortisone (Plenadren)
What this could lead to
If it works, this could offer a more convenient once-daily treatment option that improves cholesterol, blood sugar, and quality of life for people with congenital adrenal hyperplasia.
What could go wrong
This is a Phase 4 open-label study, so results may be influenced by participants knowing which treatment they receive. The improvement over standard therapy may be modest, and not all patients may respond well.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2016

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * males and females aged \>18 years; * established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency; * stably treated with conventional glucocorticoids, available to change their regimen according to random allocation * written informed consent/assent to participate in the study in compliance with local regulations. Exclusion Criteria: * clinical or laboratory signs of severe cerebral, respiratory, hepatobiliary or pancreatic diseases, renal dysfunction, gastrointestinal emptying, or motility disturbances (i.e. chronic diarrhea), significant psychiatric illnesses; * history of/or current alcohol and/or drug abuse; * night shift workers; * underlying diseases that could necessitate treatment with glucocorticoids; * therapies with hepatic enzyme induction drugs interfering with glucocorticoid kinetics, or immunosuppressive steroid therapy; * patients with a documented intolerance/known hypersensitivity to dual release hydrocortisone; * vulnerable populations, such as elderly, cancer patients, pregnant and lactating women; * history of non-compliance to medical regimens, or potentially unreliable patients

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital adrenal hyperplasia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Federico II University

    RECRUITING

    Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.