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NCT00285207 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
A Phase 2 study of Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia, sponsored by Tigris Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
- 20
- Study locations
NCT00285207 is a Phase 2 study of Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia that has completed, run by Tigris Pharmaceuticals. The registered enrollment target is 147 participants, below the 246-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT00285207, a Phase 2 study of Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia, has completed, sponsored by Tigris Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
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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, categorized as Phase 2. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (40% lower). The listed sponsor is Tigris Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT00285207 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Arizona.
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.
What interventions are being tested in trial NCT00285207?
The interventions under investigation include: placebo (DRUG), A007 (DRUG).
Who is sponsoring clinical trial NCT00285207?
This trial is sponsored by Tigris Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
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