Trial · NCT05063994
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
NCT05063994, Phase 3, Completed, Neurocrine UK Limited; results first posted 2025-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia. Trials, record NCT05063994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05063994
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
- NCT number
- NCT05063994
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Congenital Adrenal Hyperplasia
- Interventions
- Chronocort, Cortef, Placebo
- First posted
- 2021-10-01
- Last updated
- 2026-10-02
- Results first posted
- 2025-02-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Were Biochemical Responders at Week 28 | 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. |
| Secondary | Percentage of Participants Who Were Dose Responders at Week 28 | 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. |
| Secondary | Total Daily Dose of Hydrocortisone at Week 28 | 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. |
| Secondary | Number of Participants in Biochemical Control | Baseline and Week 28 | 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. |
| Secondary | Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28 | Baseline, 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. |
| Secondary | Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28 | Baseline, 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. |
| Secondary | Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28 | 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. |
| Secondary | Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only) | Week 28 | Assessment of efficacy at Week 28 was a composite of each participant's on-treatment visit closest in time to 28 weeks post randomization. |
| Secondary | Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28 | Baseline, 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Were Biochemical Responders at Week 28 | Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Were Dose Responders at Week 28 | Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Total Daily Dose of Hydrocortisone at Week 28 | Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. | mg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants in Biochemical Control | Baseline and Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Mean of 08:00 and 13:00 17-OHP Levels at Week 28 | Baseline, Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure. | ng/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean of 08:00 and 13:00 A4 Levels at Week 28 | Baseline, Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Participants with evaluable data for the endpoint were analyzed for this outcome measure. | ng/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Menstrual Regularity (Females of Childbearing Potential Only) at Week 28 | Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only female participants of childbearing potential with evaluable data for the endpoint were analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Luteinizing Hormone Levels (Males Only) at Week 28 | Baseline, Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only male participants with evaluable data for the endpoint were analyzed for this outcome measure. | mIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Size of Testicular Adrenal Rest Tumors at Week 28 (Males Only) | Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only male participants with evaluable data for the endpoint were analyzed for this outcome measure. | percent change | MEAN |
| SECONDARY | Change From Baseline in Hirsutism at Week 28 Using the Ferriman-Gallwey Score (Females Only) at Week 28 | Baseline, Week 28 | FAS: All participants with CAH who were randomized into the study and who received at least 1 dose of study drug. Only female participants with evaluable data for the endpoint were analyzed for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Biochemical Responders at Week 28 | Chronocort | 40.0 | percentage of participants | ||
| Percentage of Participants Who Were Biochemical Responders at Week 28 | Cortef | 14.3 | percentage of participants | ||
| Percentage of Participants Who Were Dose Responders at Week 28 | Chronocort | 36.0 | percentage of participants | ||
| Percentage of Participants Who Were Dose Responders at Week 28 | Cortef | 10.7 | percentage of participants | ||
| Total Daily Dose of Hydrocortisone at Week 28 | Chronocort | 20.2 | 95% Confidence Interval 17.8 to 22.6 | mg | |
| Total Daily Dose of Hydrocortisone at Week 28 | Cortef | 26.0 | 95% Confidence Interval 23.7 to 28.3 | mg | |
| Number of Participants in Biochemical Control | Chronocort | Baseline | 13 | Participants | |
| Number of Participants in Biochemical Control | Cortef | Baseline | 8 | Participants | |
| Number of Participants in Biochemical Control | Chronocort | Week 28 | 10 | Participants | |
| Number of Participants in Biochemical Control | Cortef | Week 28 | 4 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cortef Run-In | STARTED | Cortef Run-In | 55 | |
| Cortef Run-In | STARTED | Chronocort | 0 | |
| Cortef Run-In | STARTED | Cortef | 0 | |
| Cortef Run-In | COMPLETED | Cortef Run-In | 53 | |
| Cortef Run-In | COMPLETED | Chronocort | 0 | |
| Cortef Run-In | COMPLETED | Cortef | 0 | |
| Cortef Run-In | NOT COMPLETED | Cortef Run-In | 2 | |
| Cortef Run-In | NOT COMPLETED | Chronocort | 0 | |
| Cortef Run-In | NOT COMPLETED | Cortef | 0 | |
| Treatment | STARTED | Cortef Run-In | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Cortef Run-In | 0 | 55 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Chronocort | 0 | 25 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Cortef | 2 | 28 | 2 |
| other | Gastroenteritis | Infections and infestations | Cortef Run-In | 0 | 55 | 0 |
| other | Gastroenteritis | Infections and infestations | Chronocort | 2 | 25 | 2 |
| other | Gastroenteritis | Infections and infestations | Cortef | 2 | 28 | 2 |
| other | Fatigue | General disorders | Cortef Run-In | 0 | 55 | 0 |
| other | Fatigue | General disorders | Chronocort | 4 | 25 | 6 |
| other | Fatigue | General disorders | Cortef | 5 | 28 | 5 |
| other | Oedema peripheral | General disorders | Cortef Run-In | 1 | 55 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cortef Run-In | 0 | 55 |
| Total, all-cause mortality | Chronocort | 0 | 25 |
| Total, all-cause mortality | Cortef | 0 | 28 |
| Total, other adverse events | Cortef Run-In | 2 | 55 |
| Total, other adverse events | Chronocort | 22 | 25 |
| Total, other adverse events | Cortef | 24 | 28 |
| Total, serious adverse events | Cortef Run-In | 0 | 55 |
| Total, serious adverse events | Chronocort | 2 | 25 |
| Total, serious adverse events | Cortef | 1 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05063994
GET https://conductscience.org/api/trials/v1/NCT05063994/results?page=2