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NCT00106691 · ClinicalTrials.gov registry record · Phase 3

Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

A Phase 3 study, sponsored by GTx.

Completed
Registry status
Phase 3
Development phase
1,589
Enrollment target

NCT00106691: Completed Phase 3 study, sponsored by GTx.

NCT00106691 is a Phase 3 study that has completed, run by GTx. The registered enrollment target is 1,589 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00106691, a Phase 3 study, has completed, sponsored by GTx.

COMPLETED
Registry status
Phase 3
Development phase
1,589 participants
Enrollment target

Study Summary

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

Primary Outcome

To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)

Interventions

  • DRUG Placebo
  • DRUG Toremifene 20 mg

Trial Details

FieldValue
Enrollment Target 1,589 participants
Start Date 2005-01
Est. Completion 2010-02
Phase Phase 3
GTx

15 total trials

What the finished NCT00106691 record still lists

NCT00106691 is an interventional study that assigns participants to a tested intervention. Its 1,589 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00106691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00106691 about?

NCT00106691 is a clinical study titled "Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)". The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

What is the current status of trial NCT00106691?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,589 participants. The study started on 2005-01. Estimated completion is 2010-02.

What interventions are being tested in trial NCT00106691?

The interventions under investigation include: Placebo (DRUG), Toremifene 20 mg (DRUG).

Who is sponsoring clinical trial NCT00106691?

This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00106691's enrollment target sits among peer trials

1,589 149th of 2000 higher than 1,852 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00106691, the US trial registry maintained by the National Library of Medicine. NCT00106691 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.