A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
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% of sexually active women will become infected during their lifetime with
human papillomavirus and 50% of these infections will be due to high-risk human
papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a
very substantial number of women are left with uncertainty regarding whether their infection
will clear spontaneously or progress to cancer.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to clearance of high-risk human papillomavirus infection.
At each visit
No
Medical Director
Study Director
Takeda
United States: Food and Drug Administration
1537-851B
NCT00117884
April 2006
June 2008
Name | Location |
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Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
Hackensack, New Jersey 07601 | |
Denver, Colorado | |
Charlotte, North Carolina | |
Tulsa, Oklahoma |