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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


Phase 2
18 Years
40 Years
Not Enrolling
Female
Papillomavirus Infections

Thank you

Trial Information

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.


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.

Type of Study:

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

Outcome Measure:

Time to clearance of high-risk human papillomavirus infection.

Outcome Time Frame:

At each visit

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Takeda

Authority:

United States: Food and Drug Administration

Study ID:

1537-851B

NCT ID:

NCT00117884

Start Date:

April 2006

Completion Date:

June 2008

Related Keywords:

  • Papillomavirus Infections
  • Papillomavirus infections;
  • Cervix Dysplasia
  • Papillomavirus Infections

Name

Location

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