A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Trial of the Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in
a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy
confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat
themselves with gel applied to the cervix via an intravaginal applicator. Patients will
apply gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will
return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic
testing.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Pathological Response
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
baseline and 4 months
No
John A Burigo, MD
Principal Investigator
OB/GYN Specialists of the Palm Beaches
United States: Food and Drug Administration
TG-001
NCT00285207
January 2006
June 2008
Name | Location |
---|---|
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Arrowhead Regional Medical Center | Colton, California 92324-1819 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Medical College of Georgia | Augusta, Georgia 30912 |
Jacobi Medical Center | Bronx, New York 10461 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Jersey Shore University Medical Center | Neptune, New Jersey 07754 |
HOPE Research Institute, LLC | Phoenix, Arizona 85032 |
Visions Clinical Research | Boynton Beach, Florida 33472 |
University of Alabama Highlands, Dept. of OB/GYN | Birmingham, Alabama 35205 |
Visions Clinical Research-Tucson | Tucson, Arizona 85712 |
Northern California Research Corp | Carmichael, California 95608 |
Robin Black OGNP | Costa Mesa, California 92629 |
IGO Medical Group of San Diego | San Diego, California 92121 |
Coastal Connecticut Research, LLC | New London, Connecticut 06320 |
Global OB/GYN Centers of Florida | Pembroke Pines, Florida 33024 |
Physician Care Clinical Research, LLC. | Sarasota, Florida 34239 |
OB/GYN Specialists of the Palm Beaches | West Palm Beach, Florida 33401 |
Mount Vernon Clinical Research, LLC | Atlanta, Georgia 30328 |
East Jefferson OB/GYN | Metairie, Louisiana 70006 |
Office of R. Garn Mabey, MD | Las Vegas, Nevada 89128 |
Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health | Bronx, New York 10461 |
New York Downtown Hospital | New York, New York 10038 |
Greater Cincinnati OB/GYN, Inc. | Cincinnati, Ohio 45267 |
University of Oklahoma Health Sciences Center Dept of OB/GYN | Oklahoma City, Oklahoma 73104 |
Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services | Pittsburgh, Pennsylvania 15213 |
Hill Country OB/GYN | Austin, Texas 78737 |
Planned Parenthood of Houston & Southeast Texas, Inc. | Houston, Texas 77004 |
4601 Old Shepard Place; Bldg 2, Suite 201 | Plano, Texas 75093 |