Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Recruiting in Palo Alto (17 mi)
+91 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Takeda
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
A female subject of childbearing potential who is sexually active using contraception.
Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration.
Subject must be neither pregnant nor lactating from Screening throughout the duration of the study.
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Treatment Details
Interventions
- 851B (Virus Therapy)
Participant Groups
11Treatment groups
Experimental Treatment
Placebo Group
Group I: 7Experimental Treatment1 Intervention
Group II: 6Experimental Treatment1 Intervention
Group III: 5Experimental Treatment1 Intervention
Group IV: 4Experimental Treatment1 Intervention
Group V: 3Experimental Treatment1 Intervention
Group VI: 2Experimental Treatment1 Intervention
Group VII: 1Experimental Treatment1 Intervention
Group VIII: 8Placebo Group1 Intervention
Group IX: 9Placebo Group1 Intervention
Group X: 10Placebo Group1 Intervention
Group XI: 11Placebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00312286Danbury, CT
NCT00312286Evansville, IN
NCT00312286Las Vegas, NV
NCT00312286Gallipolis, OH
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Who Is Running the Clinical Trial?
TakedaLead Sponsor