Trial · NCT00519818
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
NCT00519818, Phase 1, Phase 2, Completed, Neurocrine UK Limited; results first posted 2014-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia. Trials, record NCT00519818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00519818
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
- NCT number
- NCT00519818
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency, Adrenogenital Syndrome
- Interventions
- Chronocort, Cortef
- First posted
- 2007-08-23
- Last updated
- 2022-04-26
- Results first posted
- 2014-08-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). | Cortef after one week, Chronocort after one month | |
| Secondary | 17 Hydroxyprogesterone at 08.00 Hours | Cortef after one week compared with Chronocort after one month |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). | Cortef after one week, Chronocort after one month | Per protocol | h*nmol/l | MEAN |
| SECONDARY | 17 Hydroxyprogesterone at 08.00 Hours | Cortef after one week compared with Chronocort after one month | nmol/l | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). | Cortef | 5380 | Standard Error 414 | h*nmol/l | |
| Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose). | Chronocort | 3973 | Standard Error 166 | h*nmol/l | |
| 17 Hydroxyprogesterone at 08.00 Hours | Cortef | 16.4 | Standard Deviation 27.9 | nmol/l | |
| 17 Hydroxyprogesterone at 08.00 Hours | Chronocort | 86.9 | Standard Deviation 181.7 | nmol/l |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cortef Then Chronocort | 14 | |
| Overall Study | COMPLETED | Cortef Then Chronocort | 14 | |
| Overall Study | NOT COMPLETED | Cortef Then Chronocort | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Headache | Nervous system disorders | Chronocort | 4 | 14 | 4 |
| other | Headache | Nervous system disorders | Cortef | 3 | 14 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronocort | ||
| Total, all-cause mortality | Cortef | ||
| Total, other adverse events | Chronocort | 4 | 14 |
| Total, other adverse events | Cortef | 3 | 14 |
| Total, serious adverse events | Chronocort | 0 | 14 |
| Total, serious adverse events | Cortef | 0 | 14 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Chronocort vs Cortef: serious adverse events |
Source Trial comparisons
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00519818
GET https://conductscience.org/api/trials/v1/NCT00519818/registered