Status:
TERMINATED
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Lead Sponsor:
Takeda
Conditions:
Papillomavirus Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief 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.
Detailed Description
Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% ...
Eligibility Criteria
Inclusion
- Willing to be on acceptable method of birth control
- Have a Pap smear result of LSIL or ASCUS
- Is high risk HPV positive
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00117884
Start Date
April 1 2006
End Date
June 1 2008
Last Update
August 19 2016
Active Locations (23)
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1
Colton, California, United States, 92324
2
San Diego, California, United States, 92108
3
Colorado Springs, Colorado, United States, 80910
4
Boynton Beach, Florida, United States, 33461