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NCT01495910 · ClinicalTrials.gov registry record · Phase 1
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
A Phase 1 study of 21-Hydroxylase Deficiency, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 3
- Study locations
NCT01495910: Completed Phase 1 study of 21-Hydroxylase Deficiency, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01495910 is a Phase 1 study of 21-Hydroxylase Deficiency that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495910, a Phase 1 study of 21-Hydroxylase Deficiency, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.
Primary Outcome
Normalization or reduction of age-appropriate androstenedione levels will be determined by the mean of the androstenedione values measured on Study Days 6 and 7 of the treatment period.
Conditions Studied
Interventions
- DRUG Abiraterone acetate
Study Locations (3)
Illinois
- - Chicago
Michigan
- - Ann Arbor
Texas
- - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT01495910 record still lists
NCT01495910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with 21-Hydroxylase Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Abiraterone acetate is the first listed.
NCT01495910 reports a single indexed study location in Illinois, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT01495910 about?
NCT01495910 is a clinical study titled "A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency". The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.
What is the current status of trial NCT01495910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-12. Estimated completion is 2013-02.
What conditions does trial NCT01495910 study?
This clinical trial studies the following conditions: 21-Hydroxylase Deficiency.
What interventions are being tested in trial NCT01495910?
The interventions under investigation include: Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT01495910?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01495910 being conducted?
This trial has 3 study locations across Illinois, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 21-Hydroxylase Deficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01495910's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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