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

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

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Interventions

DRUG

placebo

5 days of 28 day cycle for 2 cycles

DRUG

A007

5 days of 28 day cycle

Sponsors & Collaborators

• Tigris Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• John A Burigo, MD · OB/GYN Specialists of the Palm Beaches

• Ramon Cestero, MD · Arrowhead Regional Medical Center

• Paul M Fine, MD · Planned Parenthood of Houston & Southeast Texas, Inc.

• Keith A Aqua, MD · Visions Clinical Research

• Steven C Blank, MD · Mount Vernon Clinical Research, LLC

• Douglas G Young, MD · Northern California Research Corp

• Allan T Sawyer, MD · Hope Research Institute, LLC

• Mark H Einstein, MD · Montefiore Medical Center-Weiler Division

• Robert M Spitz, MD · Coastal Connecticut Research, LLC

• Thomas A deHoop, MD · Greater Cincinnati OB/GYN, Inc.

• Lance R Bruck, MD · Jacobi Medical Center

• Warner K Huh, MD · University of Alabama Highlands, Dept. of OB/GYN

• Giuseppe Del Priore, MD · New York Presbyterian Hospital

• Michael A Gold, MD · University of Oklahoma Health Sciences Center Dept of OB/GYN

• Richard S Guido, MD · Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services

• Philip E Young, MD · IGO Medical Group of San Diego

• Daron G. Ferris, MD · Augusta University

• Cynthia J Goldberg, MD · Visions Clinical Research-Tucson

• Ana Eduardo, MD · Hill Country OB/GYN

• Phyllis Gee, MD · OB/GYN

• Robert Pfeffer, MD · Robin Black OGNP, Costa Mesa California

• Jonathan A Cosin, MD · Medstar Health Research Institute

• James A Williams, MD · South Carolina Oncology Associates

• Vincent A Culotta, Jr, MD · East Jefferson OB/GYN

• G. Michael Swor, MD · Physician Care Clinical Research, LLC.

• Garn R Mabey, MD · Office of R. Garn Mabey, MD

• Martin Martino, MD · Lehigh Valley Hospital

• Robert Klein, MD · Global OB/GYN Centers of Florida

• William J Mann, MD · Jersey Shore University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2008-04-30

Completion

2008-06-30

Countries

• United States

Study Locations