Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia, sponsored by Tigris Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
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 |
What the finished NCT00285207 record still lists
NCT00285207 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 246-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (40% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cervical Intraepithelial Neoplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
RECRUITING · Phase 2
-
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
COMPLETED · Phase 2
-
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
RECRUITING · Phase 1
-
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
RECRUITING · Phase 4
-
A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings
ACTIVE NOT RECRUITING · NA
-
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04396613 · 147 participants · NA
Wound Closure Techniques in Primary Spine Surgery
- NCT04851119 · 147 participants · Phase 1
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
- NCT05523947 · 147 participants · Phase 1
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
- NCT06121843 · 147 participants · Phase 1
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia