Overview
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Status:
Terminated
Terminated
Trial end date:
2008-06-01
2008-06-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Takeda
Criteria
Inclusion Criteria:- Willing to be on acceptable method of birth control
- Have a Pap smear result of LSIL or ASCUS
- Is high risk HPV positive
Exclusion Criteria:
- No evidence of high-grade disease or glandular abnormalities,
- Complete visualization of all lesion margins and the transformation zone,
- No uncontrolled significant medical illness or sexually transmitted infections,
- Taking any restricted medications such as interferon, immunomodulators, cytotoxic
drugs, investigational drugs, steroids.