Androgen Reduction in Congenital Adrenal Hyperplasia
Public ClinicalTrials.gov record NCT03548246. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to have elevated circulating levels of androgens, which can accelerate skeletal maturation and adversely impact adult height. Additionally, these children require supraphysiologic doses of hydrocortisone to suppress secretion of adrenal androgen precursors, and this treatment can retard linear growth. This study seeks to use oral abiraterone acetate (Zytiga)as an adjunct to approved CAH therapy (oral hydrocortisone and fludrocortisone) for pre-pubescent children with classic 21-hydroxylase deficiency in order to reduce daily requirement of hydrocortisone.
Study identification
- NCT ID
- NCT03548246
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 9 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2022
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
- Last update posted
- Jan 31, 2023
2023 – 2026
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| National Institutes of Health | Bethesda | Maryland | 20892 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Children's Medical Center | Dallas | Texas | 75235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Congenital Adrenal Hyperplasia trials
Other public records listing Congenital Adrenal Hyperplasia. Sorted by last update posted; newest first. Not a recommendation.
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- NCT04490915: Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia Active, not recruiting
- NCT07159841: A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH) Recruiting
- NCT05669950: A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia Recruiting
- NCT04783181: A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03548246, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03548246 live on ClinicalTrials.gov.