Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285207
Status:
COMPLETED
Last Update Posted:
2010-10-11
First Post:
2006-01-30
Brief Title:
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions HSIL of the Cervix
Sponsor:
Tigris Pharmaceuticals
Organization:
Tigris Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Trial of the Use of 44-Dihydroxybenzophenone-24-Dinitrophenyl-hydrazone A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions HSIL of the Cervix
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a randomized double-blind placebo-controlled study It will randomize patients in a 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None