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COMPLETED Phase 3

Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

NCT00449982 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

Conditions Studied

Interventions

  • DRUG Polyphenon E Ointment 10%, Polyphenon E Ointment 15%

Study Locations (12)

Other

  • — Buenos Aires
  • — Santiago, Temuco
  • — Colombia, Bogota, Medellin, Risaralda
  • — Cuautitlan, Mexico, Guadalajara, Durango, Ciliacan, Puebla
  • — Lima, Calao
  • — Bucaresti, Brasov, Iasi, Cluj-Napoca

California

  • — Davis, San Diego

Colorado

  • — Denver

New York

  • — New York

Oregon

  • — Portland

Texas

  • — Houston, Dallas, Austin

Vermont

  • — Burlington

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2003-07
Est. Completion 2004-08
Phase Phase 3

Sponsor

MediGene

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00449982

The ClinicalTrials.gov registry entry for NCT00449982 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 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediGene, which has 2 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 Condylomata Acuminata appearing as the primary indexed condition, and to 1 intervention — of which Polyphenon E Ointment 10%, Polyphenon E Ointment 15% 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: NCT00449982 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Colorado. 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 NCT00449982 about?

NCT00449982 is a clinical study titled "Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts". The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

What is the current status of trial NCT00449982?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2003-07. Estimated completion is 2004-08.

What conditions does trial NCT00449982 study?

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

What interventions are being tested in trial NCT00449982?

The interventions under investigation include: Polyphenon E Ointment 10%, Polyphenon E Ointment 15% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00449982?

This trial is sponsored by MediGene, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00449982 being conducted?

This trial has 12 study locations across California, Colorado, New York, Oregon, Texas. 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