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NCT00001521 · ClinicalTrials.gov registry record · Phase 3
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia
A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT00001521 is a Phase 3 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 66 participants.
The verdict
NCT00001521, a Phase 3 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study Summary
This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls, and divide them into 2 groups based on the medications given. Group one will receive the new four-drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four-drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four-drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until two years after their first menstrual period or until adult height. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height.
Interventions
- DRUG Letrozole
- DRUG Flutamide
- DRUG Hydrocortisone
- DRUG Fludrocortisone
- DRUG Testolactone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 1995-06-08 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001521
The ClinicalTrials.gov registry entry for NCT00001521 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT00001521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001521 about?
NCT00001521 is a clinical study titled "Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia". This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls, and divide them into 2 groups based...
What is the current status of trial NCT00001521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 1995-06-08. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT00001521?
The interventions under investigation include: Letrozole (DRUG), Flutamide (DRUG), Hydrocortisone (DRUG), Fludrocortisone (DRUG), Testolactone (DRUG).
Who is sponsoring clinical trial NCT00001521?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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