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COMPLETED Phase 3

Treatment of Erectile Dysfunction I

NCT01037244 · View on ClinicalTrials.gov ↗

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)

California

  • Warner Chilcott Investigational Site — Laguna Hills
  • Warner Chilcott Investigational Site — Newport Beach
  • Warner Chilcott Investigational Site — San Diego
  • Warner Chilcott Investigational Site — Torrance

Arizona

  • Warner Chilcott Investigational Site — Mesa
  • Warner Chilcott Investigational Site — Phoenix
  • Warner Chilcott Investigational Site — Tucson

Connecticut

  • Warner Chilcott Investigational Site — Middlebury
  • Warner Chilcott Investigational Site — New Britain
  • Warner Chilcott Investigational Site — Waterbury

Florida

  • Warner Chilcott Investigational Site — Clearwater
  • Warner Chilcott Investigational Site — Miami
  • Warner Chilcott Investigational Site — Ocala

Alabama

  • Warner Chilcott Investigational Site — Birmingham
  • Warner Chilcott Investigational Site — Homewood

Colorado

  • Warner Chilcott Investigational Site — Denver

Georgia

  • Warner Chilcott Investigational Site — Columbus

Illinois

  • Warner Chilcott Investigational Site — Melrose Park

Trial Details

FieldValue
Enrollment Target 618 participants
Start Date 2009-09
Est. Completion 2010-03
Phase Phase 3

Sponsor

Warner Chilcott

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01037244

The ClinicalTrials.gov registry entry for NCT01037244 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 618 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01037244 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Arizona, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01037244 about?

NCT01037244 is a clinical study titled "Treatment of Erectile Dysfunction I". 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 NCT01037244?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2009-09. Estimated completion is 2010-03.

What conditions does trial NCT01037244 study?

This clinical trial studies the following conditions: Erectile Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01037244?

The interventions under investigation include: Placebo (DRUG), Udenafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01037244?

This trial is sponsored by Warner Chilcott, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01037244 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.

Related

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