Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
NCT ID: NCT00117884
Last Updated: 2016-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
240 participants
INTERVENTIONAL
2006-04-30
2008-06-30
Brief Summary
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Detailed Description
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Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
2
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
3
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
4
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
5
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
6
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
7
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
8
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
9
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
10
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
11
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Interventions
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851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Eligibility Criteria
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Inclusion Criteria
* Have a Pap smear result of LSIL or ASCUS
* Is high risk HPV positive
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Colton, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Boynton Beach, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Savannah, Georgia, United States
Louisville, Kentucky, United States
Detroit, Michigan, United States
Moorestown, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Renton, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Québec, Quebec, Canada
Countries
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Other Identifiers
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U1111-1127-5850
Identifier Type: REGISTRY
Identifier Source: secondary_id
1537-851B
Identifier Type: -
Identifier Source: org_study_id
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