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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00117884 |
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.
Condition | Intervention | Phase |
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Papillomavirus Infections |
Drug: 851B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 240 |
Study Start Date: | April 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: 851B
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
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2: Experimental |
Drug: 851B
851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
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3: Experimental |
Drug: 851B
851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
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4: Experimental |
Drug: 851B
851B 3.0% formulation, gel, topically, once a week for 1 cycle.
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5: Experimental |
Drug: 851B
851B 3.0% formulation, gel, topically, once a week for 2 cycles.
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6: Experimental |
Drug: 851B
851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
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7: Experimental |
Drug: 851B
851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
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8: Experimental |
Drug: 851B
851B placebo-matching gel, topically, once a week for 1 cycle.
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9: Experimental |
Drug: 851B
851B placebo-matching gel, topically, twice a week for 1 cycle.
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10: Experimental |
Drug: 851B
851B placebo-matching gel, topically, once a week for 2 cycles.
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11: Experimental |
Drug: 851B
851B placebo-matching gel, topically, twice a week for 2 cycles.
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 1537-851B |
Study First Received: | July 1, 2005 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00117884 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Papillomavirus infections; Cervix Dysplasia |
Virus Diseases DNA Virus Infections Papillomavirus Infections Congenital Abnormalities Uterine Cervical Dysplasia |
Virus Diseases Communicable Diseases Tumor Virus Infections |
DNA Virus Infections Papillomavirus Infections Infection |