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

Stopped early · Phase 2

Conditions studied: Papillomavirus Infections

In brief

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.

Key facts

Study ID

NCT00117884

Run by

Takeda

People needed

240

Starts

2006-04-01

Expected to finish

2008-06-01

Last updated by the study team

2016-08-19

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Colton, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Louisville, Kentucky, United States
• Study site — Detroit, Michigan, United States
• Study site — Moorestown, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Renton, Washington, United States
• Study site — Seattle, Washington, United States
• Study site — Spokane, Washington, United States
• Study site — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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