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NCT00544076 · ClinicalTrials.gov registry record · Phase 3

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

A Phase 3 study, sponsored by City of Hope Medical Center.

Terminated
Registry status
Phase 3
Development phase
110
Enrollment target

NCT00544076: Clinical Trial Phase 3 study, sponsored by City of Hope Medical Center.

NCT00544076 is a Phase 3 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00544076, a Phase 3 study, was terminated before completion, sponsored by City of Hope Medical Center.

TERMINATED
Registry status
Phase 3
Development phase
110 participants
Enrollment target

Study Summary

RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction. PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.

Primary Outcome

Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test

Interventions

  • OTHER questionnaire administration
  • PROCEDURE quality-of-life assessment
  • DRUG sildenafil citrate
  • DRUG alprostadil
  • PROCEDURE robotic-assisted laparoscopic surgery

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2006-01
Est. Completion 2012-04
Phase Phase 3
City of Hope Medical Center

582 total trials

Why NCT00544076 stopped before completion

NCT00544076 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 5 interventions - of which questionnaire administration is the first listed.

NCT00544076 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00544076 about?

NCT00544076 is a clinical study titled "ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer". RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction. PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing ro...

What is the current status of trial NCT00544076?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2006-01. Estimated completion is 2012-04.

What interventions are being tested in trial NCT00544076?

The interventions under investigation include: questionnaire administration (OTHER), quality-of-life assessment (PROCEDURE), sildenafil citrate (DRUG), alprostadil (DRUG), robotic-assisted laparoscopic surgery (PROCEDURE).

Who is sponsoring clinical trial NCT00544076?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00544076's enrollment target sits among peer trials

110 1657th of 2000 higher than 337 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 NCT00544076, the US trial registry maintained by the National Library of Medicine. NCT00544076 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.