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COMPLETED Phase 2

Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

NCT00285207 · View on ClinicalTrials.gov ↗

Study Summary

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

Interventions

  • DRUG placebo
  • DRUG A007

Study Locations (20)

California

  • Northern California Research Corp — Carmichael
  • Arrowhead Regional Medical Center — Colton
  • Robin Black OGNP — Costa Mesa
  • IGO Medical Group of San Diego — San Diego

Florida

  • Visions Clinical Research — Boynton Beach
  • Global OB/GYN Centers of Florida — Pembroke Pines
  • Physician Care Clinical Research, LLC. — Sarasota
  • OB/GYN Specialists of the Palm Beaches — West Palm Beach

Arizona

  • Hope Research Institute, LLC — Phoenix
  • Visions Clinical Research-Tucson — Tucson

Georgia

  • Mount Vernon Clinical Research, LLC — Atlanta
  • Medical College of Georgia — Augusta

New York

  • New York Downtown Hospital — New York
  • Jacobi Medical Center — The Bronx

Alabama

  • University of Alabama Highlands, Dept. of OB/GYN — Birmingham

Connecticut

  • Coastal Connecticut Research, LLC — New London

District of Columbia

  • Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 147 participants
Start Date 2006-01
Est. Completion 2008-06
Phase Phase 2

Sponsor

Tigris Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00285207

The ClinicalTrials.gov registry entry for NCT00285207 describes a study currently listed as completed. It is categorized as Phase 2, 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 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tigris Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Cervical Intraepithelial Neoplasia 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: NCT00285207 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT00285207 about?

NCT00285207 is a clinical study titled "Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix". A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

What is the current status of trial NCT00285207?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2006-01. Estimated completion is 2008-06.

What conditions does trial NCT00285207 study?

This clinical trial studies the following conditions: Cervical Intraepithelial Neoplasia, Uterine Cervical Dysplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00285207?

The interventions under investigation include: placebo (DRUG), A007 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00285207?

This trial is sponsored by Tigris Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00285207 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. 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