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NCT00028353 · ClinicalTrials.gov registry record · Phase 2
A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)
A Phase 2 study, sponsored by GTx.
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
NCT00028353: Completed Phase 2 study, sponsored by GTx.
NCT00028353 is a Phase 2 study that has completed, run by GTx. The registered enrollment target is 500 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00028353, a Phase 2 study, has completed, sponsored by GTx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
Study Summary
If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high grade PIN and prevent the occurrence of prostate cancer. This study is currently enrolling up to 500 men at approximately 60 locations in the United States.
Interventions
- DRUG GTX-006 (Acapodene)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2001-04 |
| Est. Completion | 2003-07 |
| Phase | Phase 2 |
What the finished NCT00028353 record still lists
NCT00028353 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher).
The record links to 0 conditions, and to 1 intervention - of which GTX-006 (Acapodene) is the first listed.
NCT00028353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00028353 about?
NCT00028353 is a clinical study titled "A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN)". If you are a male 30 years of age or older and have a positive diagnosis of high grade (II or III) prostate Intraepithelial Neoplasia (PIN) or have had an abnormal/suspicious prostate biopsy, you may be eligible for this study. This is a study of an investigational medication that may reduce high gr...
What is the current status of trial NCT00028353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2001-04. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00028353?
The interventions under investigation include: GTX-006 (Acapodene) (DRUG).
Who is sponsoring clinical trial NCT00028353?
This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00028353's enrollment target sits among peer trials
500 70th of 2000 higher than 1,927 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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