A Phase 3 interventional study of Chronocort® and Standard Care in Congenital Adrenal Hyperplasia, sponsored by Neurocrine UK Limited. Withdrawn at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Neurocrine UK Limited (formerly part of Neurocrine Biosciences) · Phase 3, Interventional, and Treatment
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Among 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital — 1 open to participants now, 1 under way, none of them phase 3. Hydrocortisone · Adrenal Hyperplasia, Congenital.
Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, this one is the 17th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 3, and was the 12th registered.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
Browse Adrenal Hyperplasia, Congenital studies →1 of the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital is open now, in 1 country. Recruiting first, the newest first:
Federico II University · Sites in Italy
Ages 18+
By country, each count listing its studies:
Hydrocortisone: first FDA approval 1951 (HYDROCORTONE), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 20 Adrenal Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; none take healthy volunteers.
This study: 16 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 6 · Phase 4 2
First in 1995; this study’s year is marked. 1 started in 2018.
Median enrollment 28 across the 17 interventional studies. Of the 13 that completed or were terminated, 8 (62%) have results posted.
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9 of 17 have an industry lead sponsor. The 9 most frequent:
This study is registered under Neurocrine UK Limited, one of the names counted as Neurocrine Biosciences. Under that name alone:
Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.
16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences: 2 open now, 5 under way, 2 of them phase 3. Of 9 finished, 7 (78%) have results posted.
Among the 16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences, this one is the 15th largest by enrollment, is one of 2 that started in 2018, is one of 6 in phase 3, and was the 8th registered.
Neurocrine Biosciences’s Adrenal Hyperplasia, Congenital studies by the year they started, since 2007.
1 of the studies testing hydrocortisone in Adrenal Hyperplasia, Congenital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03760835Federico II UniversityCongenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | 2026-12-31 |
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Among the 17 studies testing hydrocortisone in Adrenal Hyperplasia, Congenital, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Neurocrine Biosciences’s 16 in Adrenal Hyperplasia, Congenital:
This tab as a report to print or save as PDF → With an account.
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH). This study will be conducted in the USA.
It will compare the efficacy, safety and tolerability of twice daily Chronocort® with standard care (using the participant's usual individualized standard glucocorticoid regimen) over a treatment period of 52 weeks in participants aged 16 years and over with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned glucocorticoids).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply (note: if a participant fails to meet an inclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
Age
In participants aged \<18 years, height velocity must be less than 2 cm in the last year and puberty must be completed.
Type of Participant and Disease Characteristics
Participants with known CAH due to 21-hydroxylase deficiency (classic CAH) diagnosed in childhood with documented (at any time) elevated 17-OHP or A4 and currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone (or a combination of the aforementioned ).
Sex
Male and female participants
Male participants:
- A male participant must agree to use as detailed in Section 10.4 of this protocol during the treatment period and refrain from donating sperm during this period.
Female participants:
i. Not a woman of (WOCBP) as defined in Section 10.4. OR ii. A WOCBP with a negative pregnancy test at entry into the study who agrees to follow the contraceptive guidance in Section 10.4 during the treatment period.
Note: females presenting with oligomenorrhea or amenorrhea who are aged ≤55 years should be considered potentially fertile and therefore, as well as undergoing pregnancy testing like all other female participants, will be expected to be using an acceptable method of contraception which should have been ongoing for ≥90 days prior to the study.
Informed Consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply (note: if a participant meets an exclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
Medical Conditions
Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
Prior/Concomitant Therapy
Participants who are receiving \<10 mg hydrocortisone dose at baseline or the hydrocortisone dose equivalent.
Prior/Concurrent Clinical Study Experience
Participants who have previously been exposed to Chronocort in studies DIUR-003, DIUR-005 or DIUR-006.
Other Exclusions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrocortisone modified release capsules - Chronocort®. 66 subjects will be randomised to this group using an interactive web response system (IWRS).
Drug: Chronocort®
Subjects participating in this arm will continue to receive their normal, standard care (hydrocortisone, dexamethasone, prednisone, prednisolone) once enrolled on the study. 66 subjects will be randomised to this arm using an interactive web response system (IWRS).
Drug: Standard Care
Hydrocortisone modified release capsules - 5mg, 10mg and 20mg.
Also known as: Hydrocortisone modified release capsules
The subject's standard care regimen upon entering the study; this could consist of hydrocortisone, dexamethasone, prednisone or prednisolone.
Also known as: Hydrocortisone, Dexamethasone, Prednisone, Prednisolone
Non-inferiority of Chronocort® versus standard care in terms of responder rate.
The proportion of participants after 52 weeks of treatment in the Chronocort® and standard care treatment groups achieving biochemical control. Participants with 17 OHP and A4 in the optimal (for 17-OHP) and reference range (for A4) at both timepoints of 09:00 and 13:00 hours will be classified as 'in biochemical control'; if at least one of these measurements is outside of the optimal (for 17-OHP) or reference range (for A4) they will be classified as 'not in biochemical control'.
Time frame: 52 weeks
Impact of both treatments on markers of fertility.
Proportion of participants who are "responders" at Weeks 26 and 52 i.e. restoration of menses/more regular menses in women (patient diary used to record menstrual cycle details in pre menopausal women who have not had a hysterectomy and are not using hormonal contraception), and luteinizing hormone (LH) in men that was outside the normal range at baseline but moves to within the normal range during the study
Time frame: Weeks 26 & 52
Impact of both treatments on hirsutism in female participants.
Change in hirsutism will be assessed at Weeks 26 and 52 using a 10 cm VAS ranging from 'No Symptoms' to 'Very Severe Symptoms' which will be completed by the participant.
Time frame: Weeks 26 & 52
Impact of both treatments on acne.
Change in acne assessed at Weeks 26 and 52 using a 10 cm visual analogue scale (VAS) ranging from 'No Symptoms' to 'Very Severe Symptoms' which will be completed by the participant.
Time frame: Weeks 26 & 52
Impact of both treatments on glycated hemoglobin (HbA1c) levels.
Change from baseline to Weeks 26 and 52 in glycated hemoglobin (HbA1c) levels.
Time frame: Weeks 26 & 52
Impact of both treatments on waist circumference (in centimetres).
Change from baseline to Weeks 26 and 52 in waist circumference (cm).
Time frame: Weeks 26 & 52
Impact of both treatments on body weight (in kilograms).
Change from baseline to Weeks 26 and 52 in body weight (kg).
Time frame: Weeks 26 & 52
Impact of both treatments on quality of life (QoL) using SF-36® total score and the sub-domain of vitality.
Change from baseline to Weeks 26 and 52 in Quality of Life using SF-36® total score and the score for the vitality sub-domain.
Time frame: Weeks 26 & 52
Impact of both treatments on Quality of Life using Multidimensional Assessment of Fatigue (MAF).
Change from baseline to Weeks 26 and 52 in Quality of Life using Multidimensional Assessment of Fatigue (MAF).
Time frame: Weeks 26 & 52
Impact of both treatments on Quality of Life using EQ-5D™.
Change from baseline to Weeks 26 and 52 in Quality of Life using EQ-5D™.
Time frame: Weeks 26 & 52
Safety and tolerability of Chronocort® relative to standard care
Incidence of clinical AEs, with a particular focus on adrenal crises.
Time frame: 52 weeks
The need for additional glucocorticoid doses
Use of immediate release hydrocortisone from the sick day packs or use of any additional glucocorticoid treatment during the study.
Time frame: 52 weeks
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red blood cell count and platelet count
Routine haematology assessments to compare red blood cell and platelet counts (absolute values) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haemaglobin
Routine haematology assessments to compare haemaglobin concentrations (g/dL) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - haematocrit
Routine haematology assessments to compare haematocrit levels (ratio of red blood cells to total blood volume) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean corpuscular volume (MCV)
Routine haematology assessments to compare mean corpuscular volumes (volume of red blood cells) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin (MCH)
Routine haematology assessments to compare mean cell haemoglobin concentrations between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - mean cell haemoglobin concentration (MCHC)
Routine haematology assessments to compare mean cell haemoglobin concentrations (as measured by dividing haematocrit by blood haemoglobin levels) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - Red cell distribution width (RDW)
Routine haematology assessments to compare Red cell distribution width (measured in micrometres) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of routine safety haematology assessments - White blood cell count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
Routine haematology assessments to compare average White blood cell counts (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils) with differentials (absolute count and %) between the Chronocort arm and Standard Care arm.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of physical examinations.
Safety of Chronocort® compared to standard care as measured by the incidence of abnormal findings identified during physical examinations. The physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal and neurological systems for the purpose of safety monitoring and to determine subject eligibility. Investigators should pay special attention to clinical signs related to previous serious illnesses. Abnormal findings are recorded in the eCRF and are assessed for their clinical significance.
Time frame: Baseline (Day 1), Week 26 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Blood pressure
Systolic and diastolic blood pressure will be measured (in mmHg - millimetres of mercury) at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Heart rate
Heart rate will be measured (in beats per minute) at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Respiratory rate
Respiratory rate will be measured (in breaths per minute) at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of vital signs - Oral body temperature
Oral body temperature (measured in Celsius) will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Specific gravity
Specific gravity of urine (concentration of solutes) will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - pH
Urine pH (potential of hydrogen - molar concentration of hydrogen ions) will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Glucose
Urine glucose concentrations will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Proteins
Urine protein concentrations will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Blood
Concentration of blood molecules in urine will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Ketones
Urine ketone concentrations will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Bilirubin
Urine bilirubin concentrations will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of urinalysis - Urobilinogen by dipstick
Urobilinogen concentrations will be measured at each visit for safety monitoring purposes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Safety of Chronocort® compared to standard care by assessment of electrocardiogram (ECG).
A single 12-lead ECG will be recorded using an ECG machine that automatically calculates and measures PR, QRS, QT and QTc intervals (in milliseconds and voltage). ECG measurements should be preceded by 10 minutes of rest (semi-supine) in a quiet area. ECGs will be read at sites by the local investigator and any abnormal findings recorded in the eCRF and the original ECG source notes stored in the participant's source notes.
Time frame: Baseline (Day 1), Week 2, Week 6, Week 12, Week 26, Week 39 & Week 52
Plan to share: No
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Ran from Oct 2018 to primary completion in Oct 2018, 0 months.
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This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone
Adrenal Hyperplasia, Congenital →