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Sponsored by: |
Tigris Pharmaceuticals |
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Information provided by: | Tigris Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00285207 |
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.
Condition | Intervention | Phase |
---|---|---|
Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia |
Drug: A-007 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 212 |
Study Start Date: | January 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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 HSIL (CIN 2/3), 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.
Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at the month 4 visit.
The investigator is responsible for ensuring that the LEEP is conducted according to the procedures and guidelines of his/her institution.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients may be enrolled in the study only if they meet all of the following criteria:
Contraceptive sponges, IUD, spermicides, sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.
Exclusion Criteria:
Patients will be excluded from the study for any of the following preexisting reasons:
Principal Investigator: | John A Burigo, MD | OB/GYN Specialists of the Palm Beaches |
Principal Investigator: | Ramon Cestero, MD | Arrowhead Regional Medical Center |
Principal Investigator: | Paul M Fine, MD | Planned Parenthood of Houston & Southeast Texas, Inc. |
Principal Investigator: | Keith A Aqua, MD | Visions Clinical Research |
Principal Investigator: | Steven C Blank, MD | Mount Vernon Clinical Research, LLC |
Principal Investigator: | Douglas G Young, MD | Northern California Research Corp |
Principal Investigator: | Allan T Sawyer, MD | Hope Research Institute, LLC |
Principal Investigator: | Mark H Einstein, MD | Montefiore Medical Center-Weiler Division |
Principal Investigator: | Robert M Spitz, MD | Coastal Connecticut Research, LLC |
Principal Investigator: | Thomas A deHoop, MD | Greater Cincinnati OB/GYN, Inc. |
Principal Investigator: | Lance R Bruck, MD | Jacobi Medical Center |
Principal Investigator: | Warner K Huh, MD | University of Alabama Highlands, Dept. of OB/GYN |
Principal Investigator: | Giuseppe Del Priore, MD | New York Downtown Hospital |
Principal Investigator: | Michael A Gold, MD | University of Oklahoma Health Sciences Center Dept of OB/GYN |
Principal Investigator: | Richard S Guido, MD | Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services |
Principal Investigator: | Philip E Young, MD | IGO Medical Group of San Diego |
Principal Investigator: | Daron G. Ferris, MD | Medical College of Georgia |
Principal Investigator: | Cynthia J Goldberg, MD | Visions Clinical Research-Tucson |
Principal Investigator: | Ana Eduardo, MD | Hill Country OB/GYN |
Principal Investigator: | Phyllis Gee, MD | OB/GYN |
Principal Investigator: | Robert Pfeffer, MD | Robin Black OGNP, Costa Mesa California |
Principal Investigator: | Jonathan A Cosin, MD | Washington Hospital Center |
Principal Investigator: | James A Williams, MD | South Carolina Oncology Associates |
Principal Investigator: | Vincent A Culotta, Jr, MD | East Jefferson OB/GYN |
Principal Investigator: | G. Michael Swor, MD | Physician Care Clinical Research, LLC. |
Principal Investigator: | Garn R Mabey, MD | Office of R. Garn Mabey, MD |
Principal Investigator: | Martin Martino, MD | Lehigh Valley Hospital |
Principal Investigator: | Robert Klein, MD | Global OB/GYN Centers of Florida |
Principal Investigator: | William J Mann, MD | JERSEY SHORE UNIVERSITY MEDICAL CENTER |
Study ID Numbers: | TG-001 |
Study First Received: | January 30, 2006 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00285207 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3) |
Genital Diseases, Female Virus Diseases Uterine Cervical Diseases Precancerous Conditions Carcinoma in Situ Uterine Diseases |
Papilloma Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Genital Diseases, Female Uterine Cervical Diseases Neoplasms Neoplasms by Histologic Type Precancerous Conditions Carcinoma in Situ |
Uterine Diseases Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |