A Phase 3 interventional study of Chronocort and Cortef in Congenital Adrenal Hyperplasia, sponsored by Neurocrine UK Limited. Completed at 21 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Neurocrine UK Limited (formerly part of Neurocrine Biosciences) · Phase 3, Interventional, and Treatment
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
The study will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily immediate release hydrocortisone replacement therapy (IRHC) (Cortef®) in participants aged 16 years and over with known classic Congenital Adrenal Hyperplasia (CAH) due to 21 hydroxylase deficiency.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
This study's enrollment of 55 is above the median of 37 across 50 interventional studies indexed under Adrenal Hyperplasia, Congenital.
Browse Adrenal Hyperplasia, Congenital studies →Neurocrine UK Limited is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted before Neurocrine UK Limited left Neurocrine Biosciences.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
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 blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Chronocort at a starting dose of 30 milligrams (mg), with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
Drug: Chronocort · Other: Placebo
Participants received Cortef at a starting dose of 30 mg, with dose adjustments down to 25, 20, or 15 mg based on adrenal insufficiency symptoms and androgen levels. Placebo was used for dose adjustment to maintain blinding.
Drug: Cortef · Other: Placebo
Over-encapsulated hydrocortisone modified-release capsule for oral administration.
Also known as: Hydrocortisone modified-release
Over-encapsulated hydrocortisone immediate-release tablet for oral administration.
Also known as: Immediate-release hydrocortisone, IRHC
Matching placebo
Percentage of Participants Who Were Biochemical Responders at Week 28
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Week 28
Percentage of Participants Who Were Dose Responders at Week 28
Dose response was defined as a participant who a) was receiving a total daily dose of hydrocortisone of not more than 25 mg and b) was in biochemical control at the 08:00 assessment. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Week 28
Total Daily Dose of Hydrocortisone at Week 28
Least squares (LS) mean was assessed using mixed model repeated measures (MMRM). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Week 28
Number of Participants in Biochemical Control
Biochemical control was defined as both a 17-OHP concentration (assessed at 08:00) equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline and Week 28
Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28
LS mean was assessed using analysis of covariance (ANCOVA). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28
Data are presented for the number of participants with more than monthly menstrual cycles, monthly menstrual cycles, and number of participants with oligomenorrhoea and amenorrhoea. Oligomenorrhoea was defined as fewer than 9 menstrual cycles per year or cycle length \>35 days and amenorrhoea as absent menses for ≥ 3 months. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Week 28
Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only)
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Week 28
Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28
Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score \< 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score \>15 indicates moderate or severe hirsutism. The Ferriman-Gallwey score ranged from 0 to 36. Higher score indicated more hirsutism. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline in Acne Using the Global Evaluation Acne (GEA) Scale (Females Only) at Week 28
Acne severity was assessed according to GEA scale, which ranged from 0 (Clear. No lesions) to 5 (Very severe). Higher score indicated higher severity of acne. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline in Glycated Hemoglobin (HbA1c) Percent Levels at Week 28
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline in Waist Circumference at Week 28
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline in Body Weight at Week 28
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
Change From Baseline Quality of Life Using the Self-completed Medical Outcome Study 36-Item Short Form Health Survey (SF-36) Total Score for the Physical and Mental Components and the Sub-domain of Vitality at Week 28
SF-36 evaluates aspects of functional health and well-being. The physical component has 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and the mental component has 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Total scores for the physical and mental component are presented as well as the sub-scale score for vitality. Scores were summarized and transformed into a range from 0 to 100; 0=worst, and 100=best outcome. Higher scores indicated better outcome. Change from baseline is reported (positive change from baseline indicated improvement). LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
Time frame: Baseline, Week 28
| Milestone | Cortef Run-In | Chronocort | Cortef |
|---|---|---|---|
| Started | 55 | 0 | 0 |
| Completed | 53 | 0 | 0 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Withdrawal of consent | 1 | 0 | 0 |
| Withdrew: Did not meet the inclusion/exclusion criteria at end of run-in | 1 | 0 | 0 |
| Milestone | Cortef Run-In | Chronocort | Cortef |
|---|---|---|---|
| Started | 0 | 25 | 28 |
| Full analysis set (fas) population | 0 | 25 | 28 |
| Completed | 0 | 25 | 25 |
| Not completed | 0 | 0 | 3 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Withdrawal of consent | 0 | 0 | 1 |
Biochemical response was defined as a participant who a) was in biochemical control at the 08:00 assessment and b) was receiving a total daily dose of hydrocortisone of not more than 25 mg if the participant was in biochemical control at baseline or not more than 30 mg if the participant was not in biochemical control at baseline. Biochemical control was defined as both a 17-OHP concentration equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| percentage of participants | Chronocort | Cortef |
|---|---|---|
| Percentage of Participants Who Were Biochemical Responders at Week 28 | 40.0 | 14.3 |
Dose response was defined as a participant who a) was receiving a total daily dose of hydrocortisone of not more than 25 mg and b) was in biochemical control at the 08:00 assessment. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| percentage of participants | Chronocort | Cortef |
|---|---|---|
| Percentage of Participants Who Were Dose Responders at Week 28 | 36.0 | 10.7 |
Least squares (LS) mean was assessed using mixed model repeated measures (MMRM). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| mg | Chronocort | Cortef |
|---|---|---|
| Total Daily Dose of Hydrocortisone at Week 28 | 20.2 (17.8 to 22.6) | 26.0 (23.7 to 28.3) |
Biochemical control was defined as both a 17-OHP concentration (assessed at 08:00) equal to or below the upper limit for optimal control (1200 ng/dL \[36.4 nmol/L\]) and an A4 concentration equal to or below the upper limit of the reference range (150 ng/dL \[5.2 nmol/L\] for men and 200 ng/dL \[7.0 nmol/L\] for women). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| Participants | Chronocort | Cortef |
|---|---|---|
| Baseline | 13 | 8 |
| Week 28 | 10 | 4 |
LS mean was assessed using analysis of covariance (ANCOVA). Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| ng/dL | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28 | -1223.91 (-2897.42 to 449.6) | 1612.17 (-61.34 to 3285.68) |
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| ng/dL | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28 | -4.85 (-115.57 to 105.86) | 146.13 (35.42 to 256.85) |
Data are presented for the number of participants with more than monthly menstrual cycles, monthly menstrual cycles, and number of participants with oligomenorrhoea and amenorrhoea. Oligomenorrhoea was defined as fewer than 9 menstrual cycles per year or cycle length \>35 days and amenorrhoea as absent menses for ≥ 3 months. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| Participants | Chronocort | Cortef |
|---|---|---|
| More than Monthly | 0 | 0 |
| Monthly | 9 | 2 |
| Oligomenorrhoea | 2 | 4 |
| Amenorrhoea | 3 | 6 |
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| mIU/mL | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28 | 0.15 (-0.71 to 1.02) | -1.19 (-2.01 to -0.37) |
Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| percent change | Chronocort | Cortef |
|---|---|---|
| Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only) | -7.67 ± 9.220 | -0.90 ± 1.810 |
Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score \< 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score \>15 indicates moderate or severe hirsutism. The Ferriman-Gallwey score ranged from 0 to 36. Higher score indicated more hirsutism. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| score on a scale | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28 | -1.0 (-2.5 to 0.6) | -1.2 (-3.0 to 0.5) |
Acne severity was assessed according to GEA scale, which ranged from 0 (Clear. No lesions) to 5 (Very severe). Higher score indicated higher severity of acne. Change from baseline is reported (negative change from baseline indicated improvement). LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| score on a scale | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Acne Using the Global Evaluation Acne (GEA) Scale (Females Only) at Week 28 | -0.3 (-0.5 to -0.1) | -0.2 (-0.4 to 0.0) |
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| percent HbA1c | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) Percent Levels at Week 28 | -0.01 (-0.09 to 0.06) | -0.06 (-0.13 to 0.01) |
LS mean was assessed using ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| centimeters | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Waist Circumference at Week 28 | 0.867 (-1.387 to 3.121) | -1.242 (-3.496 to 1.012) |
LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| kilograms | Chronocort | Cortef |
|---|---|---|
| Change From Baseline in Body Weight at Week 28 | 1.29 (0.00 to 2.58) | -1.67 (-2.96 to -0.38) |
SF-36 evaluates aspects of functional health and well-being. The physical component has 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and the mental component has 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Total scores for the physical and mental component are presented as well as the sub-scale score for vitality. Scores were summarized and transformed into a range from 0 to 100; 0=worst, and 100=best outcome. Higher scores indicated better outcome. Change from baseline is reported (positive change from baseline indicated improvement). LS mean was assessed by ANCOVA. Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization.
| score on a scale | Chronocort | Cortef |
|---|---|---|
| Physical Component | -3.313 (-5.801 to -0.824) | -1.031 (-3.976 to 1.913) |
| Mental Component | 0.772 (-3.209 to 4.752) | 0.685 (-4.034 to 5.403) |
| Vitality Sub-domain | -0.847 (-4.354 to 2.660) | -0.002 (-4.157 to 4.153) |
Collected over Up to 30 days after last study dose (maximum treatment duration of approximately 53 weeks; median exposure = 255.0 days for Chronocort and 230.5 days for Cortef). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cortef Run-In | 0/55 (0%) | 0/55 (0%) | 2/55 (3.6%) |
| Chronocort | 0/25 (0%) | 2/25 (8%) | 22/25 (88%) |
| Cortef | 0/28 (0%) | 1/28 (3.6%) | 24/28 (85.7%) |
| Event | Cortef Run-In | Chronocort | Cortef |
|---|---|---|---|
| COVID-19Infections and infestations | 0/55 | 1/25 | 0/28 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/55 | 1/25 | 0/28 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/55 | 0/25 | 1/28 |
| Event | Cortef Run-In | Chronocort | Cortef |
|---|---|---|---|
| PyrexiaGeneral disorders | 0/55 | 0/25 | 6/28 |
| FatigueGeneral disorders | 0/55 | 4/25 | 5/28 |
| HeadacheNervous system disorders | 0/55 | 4/25 | 3/28 |
| Weight increasedInvestigations | 0/55 | 3/25 | 0/28 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/55 | 3/25 | 2/28 |
| Blood creatine phosphokinase increasedInvestigations | 0/55 | 1/25 | 3/28 |
| GastroenteritisInfections and infestations | 0/55 | 2/25 | 2/28 |
| Ear infectionInfections and infestations | 0/55 | 2/25 | 0/28 |
| SinusitisInfections and infestations | 0/55 | 2/25 | 1/28 |
| Ligament sprainInjury, poisoning and procedural complications | 0/55 | 2/25 | 0/28 |
FAS: All participants with congenital adrenal hyperplasia (CAH) who were randomized into the study and who received at least 1 dose of study drug.
| Age, Continuous(years) | Chronocort | Cortef | Total |
|---|---|---|---|
| Mean | 36.7 ± 14.68 | 31.6 ± 13.02 | 34.0 ± 13.93 |
| Sex: Female, Male(Participants) | Chronocort | Cortef | Total |
|---|---|---|---|
| Female | 16 | 16 | 32 |
| Male | 9 | 12 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Chronocort | Cortef | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 15 | 16 | 31 |
| Unknown or Not Reported | 8 | 9 | 17 |
| Race/Ethnicity, Customized(Participants) | Chronocort | Cortef | Total |
|---|---|---|---|
| White | 13 | 12 | 25 |
| Black or African American | 1 | 2 | 3 |
| Asian | 4 | 5 | 9 |
| Not Reportable | 6 | 6 | 12 |
| Unknown | 1 | 3 | 4 |
| 17-Hydroxyprogesterone (17-OHP) Level(nanograms (ng)/deciliters (dL)) | Chronocort | Cortef | Total |
|---|---|---|---|
| Mean | 3470.48 (43.5 to 16968.5) | 5595.36 (10.0 to 14641.5) | 4593.06 (10.0 to 16968.5) |
| Androstenedione (A4) Level(ng/dL) | Chronocort | Cortef | Total |
|---|---|---|---|
| Mean | 173.30 (5.0 to 1040.5) | 483.09 (5.0 to 2516.5) | 334.15 (5.0 to 2516.5) |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2022 to primary completion in Feb 2024, 20 months.
Results were first posted in Feb 2025, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, 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 →