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A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

NCT00596258 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2009-05-22

No results posted yet for this 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

  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia

Interventions

DRUG

A-007

applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix

Sponsors & Collaborators

  • Tigris Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Keith A Aqua, MD · Visions Clinical Research

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

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

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

  • Stephanie Blank, MD · NYU School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596258 on ClinicalTrials.gov