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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 is a Phase 2 study that has completed, run by GTx. The registered enrollment target is 500 participants.

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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

FieldValue
Enrollment Target 500 participants
Start Date 2001-04
Est. Completion 2003-07
Phase Phase 2

Sponsor

GTx

15 total trials

What the Registry Record Tells You About NCT00028353

The ClinicalTrials.gov registry entry for NCT00028353 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GTx, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which GTX-006 (Acapodene) is the first listed.

NCT00028353 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.