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NCT00094328 · ClinicalTrials.gov registry record · Phase 2
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
A Phase 2 study of Puberty, Precocious, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 15
- Study locations
NCT00094328: Completed Phase 2 study of Puberty, Precocious, sponsored by AstraZeneca.
NCT00094328 is a Phase 2 study of Puberty, Precocious that has completed, run by AstraZeneca. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094328, a Phase 2 study of Puberty, Precocious, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 15
- Study locations
Study Summary
The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .
Primary Outcome
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Bicalutamide
Study Locations (15)
Other
- Research Site - Montpellier
- Research Site - Chennai
- Research Site - New Dehli
- Research Site - Moscow
- Research Site - London
Alabama
- Research Site - Birmingham
Florida
- Research Site - Jacksonville
Indiana
- Research Site - Indianapolis
Minnesota
- Research Site - Minneapolis
Oklahoma
- Research Site - Tulsa
Pennsylvania
- Research Site - Philadelphia
South Carolina
- Research Site - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2004-11-22 |
| Est. Completion | 2017-12-06 |
| Phase | Phase 2 |
What the finished NCT00094328 record still lists
NCT00094328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Puberty, Precocious appearing as the primary indexed condition, and to 2 interventions - of which Anastrozole is the first listed.
NCT00094328 lists 15 locations in 11 states (Other, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT00094328 about?
NCT00094328 is a clinical study titled "Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]". The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of mu...
What is the current status of trial NCT00094328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2004-11-22. Estimated completion is 2017-12-06.
What conditions does trial NCT00094328 study?
This clinical trial studies the following conditions: Puberty, Precocious.
What interventions are being tested in trial NCT00094328?
The interventions under investigation include: Anastrozole (DRUG), Bicalutamide (DRUG).
Who is sponsoring clinical trial NCT00094328?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00094328 being conducted?
This trial has 15 study locations across Alabama, Florida, Indiana, Minnesota, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00094328's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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