Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women. - Full Text View

Purpose

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
Papillomavirus Infections	Drug: 851B	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Time to clearance of high-risk human papillomavirus infection. [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with evidence of regression to normal cytology. [ Time Frame: Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26). ] [ Designated as safety issue: No ]
Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy). [ Time Frame: At each visit ] [ Designated as safety issue: No ]
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia. [ Time Frame: Visits 1-3 as assigned by group ] [ Designated as safety issue: No ]
Time to progression of disease to precancer. [ Time Frame: Visits 1-3 as assigned by group ] [ Designated as safety issue: No ]
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load). [ Time Frame: At each visit ] [ Designated as safety issue: No ]

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
Experimental: 1	Drug: 851B 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 2	Drug: 851B 851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
Experimental: 3	Drug: 851B 851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 4	Drug: 851B 851B 3.0% formulation, gel, topically, once a week for 1 cycle.
Experimental: 5	Drug: 851B 851B 3.0% formulation, gel, topically, once a week for 2 cycles.
Experimental: 6	Drug: 851B 851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
Experimental: 7	Drug: 851B 851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 8	Drug: 851B 851B placebo-matching gel, topically, once a week for 1 cycle.
Experimental: 9	Drug: 851B 851B placebo-matching gel, topically, twice a week for 1 cycle.
Experimental: 10	Drug: 851B 851B placebo-matching gel, topically, once a week for 2 cycles.
Experimental: 11	Drug: 851B 851B placebo-matching gel, topically, twice a week for 2 cycles.

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% 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Willing to be on acceptable method of birth control
Have a Pap smear result of LSIL or ASCUS
Is high risk HPV positive

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117884

Show 23 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00117884 History of Changes
Other Study ID Numbers:	1537-851B, U1111-1127-5850
Study First Received:	July 1, 2005
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Takeda Global Research & Development Center, Inc.:

Papillomavirus infections;
Cervix Dysplasia

Additional relevant MeSH terms:

Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on May 22, 2013