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NCT01037218 · ClinicalTrials.gov registry record · Phase 3

Treatment of Erectile Dysfunction II

A Phase 3 study of Erectile Dysfunction, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
601
Enrollment target
20
Study locations

NCT01037218 is a Phase 3 study of Erectile Dysfunction that has completed, run by Warner Chilcott. The registered enrollment target is 601 participants, above the 213-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01037218, a Phase 3 study of Erectile Dysfunction, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
601 participants
Enrollment target
20
Study locations

Study Summary

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Udenafil

Study Locations (20)

Florida

  • Warner Chilcott Investigational Site - Aventura
  • Warner Chilcott Investigational Site - Daytona Beach
  • Warner Chilcott Investigational Site - DeLand
  • Warner Chilcott Investigational Site - Ocala
  • Warner Chilcott Investigational Site - Tampa

Alabama

  • Warner Chilcott Investigational Site - Birmingham
  • Warner Chilcott Investigational Site - Huntsville

California

  • Warner Chilcott Investigational Site - Chino
  • Warner Chilcott Investigational Site - Tarzana

Georgia

  • Warner Chilcott Investigational Site - Dawsonville
  • Warner Chilcott Investigational Site - Sandy Springs

Indiana

  • Warner Chilcott Investigational Site - Fort Wayne
  • Warner Chilcott Investigational Site - Greenwood

Maryland

  • Warner Chilcott Investigational Site - Elkridge
  • Warner Chilcott Investigational Site - Greenbelt

Arizona

  • Warner Chilcott Investigational Site - Tempe

Colorado

  • Warner Chilcott Investigational Site - Englewood

Trial Details

FieldValue
Enrollment Target 601 participants
Start Date 2009-09
Est. Completion 2010-04
Phase Phase 3

Sponsor

Warner Chilcott

53 total trials

What the Registry Record Tells You About NCT01037218

The ClinicalTrials.gov registry entry for NCT01037218 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 601 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 213-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (182% higher). The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Erectile Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01037218 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT01037218 about?

NCT01037218 is a clinical study titled "Treatment of Erectile Dysfunction II". Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

What is the current status of trial NCT01037218?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2009-09. Estimated completion is 2010-04.

What conditions does trial NCT01037218 study?

This clinical trial studies the following conditions: Erectile Dysfunction.

What interventions are being tested in trial NCT01037218?

The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG).

Who is sponsoring clinical trial NCT01037218?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01037218 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.