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NCT00621985 · ClinicalTrials.gov registry record · Phase 2
Dexamethasone Treatment of Congenital Adrenal Hyperplasia
A Phase 2 study of Adrenal Hyperplasia, Congenital, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00621985: Completed Phase 2 study of Adrenal Hyperplasia, Congenital, sponsored by Boston Children's Hospital.
NCT00621985 is a Phase 2 study of Adrenal Hyperplasia, Congenital that has completed, run by Boston Children's Hospital. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621985, a Phase 2 study of Adrenal Hyperplasia, Congenital, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone.
Primary Outcome
Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.
Conditions Studied
Interventions
- DRUG Hydrocortisone
- DRUG dexamethasone
Study Locations (1)
Massachusetts
- Children's Hospital Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00621985 record still lists
NCT00621985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Adrenal Hyperplasia, Congenital appearing as the primary indexed condition, and to 2 interventions - of which Hydrocortisone is the first listed.
NCT00621985 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00621985 about?
NCT00621985 is a clinical study titled "Dexamethasone Treatment of Congenital Adrenal Hyperplasia". The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the...
What is the current status of trial NCT00621985?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2008-04. Estimated completion is 2009-06.
What conditions does trial NCT00621985 study?
This clinical trial studies the following conditions: Adrenal Hyperplasia, Congenital.
What interventions are being tested in trial NCT00621985?
The interventions under investigation include: Hydrocortisone (DRUG), dexamethasone (DRUG).
Who is sponsoring clinical trial NCT00621985?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00621985 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00621985's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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