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

Stopped early · Phase 2 · Has a placebo group

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

NCT00312286

Run by

Takeda

People needed

538

Starts

2006-04-01

Expected to finish

2008-06-01

Last updated by the study team

2016-09-23

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• A female subject of childbearing potential who is sexually active using contraception.
• Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration.
• Subject must be neither pregnant nor lactating from Screening throughout the duration of the study.
• Subject has 1 of the following:
• Menstruating with a stable cycle and has at least 21 non-bleeding days.
• Amenorrheic (due to injectable or extended-cycle contraceptives).
• Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit.
• Subject has a Pap test interpretation of either low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance.
• Subject has a uterine cervical sample that is high-risk human papillomavirus positive.

You may not qualify if…

• The Subject has evidence of an uncontrolled, clinically significant medical condition as determined by the investigator.
• The Subject has a history of hemorrhagic diatheses or coagulopathy.
• The Subject has a history of toxic shock syndrome.
• The Subject has received any of the following medications in the timeframes listed below:
• 851 (in any form) or an active (non-placebo) human papillomavirus vaccine at any time prior to the screening visit.
• In the 4 weeks prior to the screening visit the subject has received:
• Interferon therapy or other therapies that promote a proinflammatory immune state, including:
• immunomodulators.
• cytotoxic drugs.
• drugs known to have major organ toxicity.
• Used a vaginal douche 72 hours prior to the screening visit.
• Received any investigational drug within 60 days of Study Day 1.
• Used in the 2 weeks prior to Study Day 1:
• oral or inhaled corticosteroids (>1000 mcg/day, fluticasone propionate >600 mg/day, or equivalent).
• systemic steroids.
• topical drugs to the anogenital area.
• NuvaRing.
• The Subject has a history of hypersensitivity to any components of the gel formulation or to iodine.
• The Subject has given birth or has had a spontaneous or induced abortion within 2 months of Study Day 1.
• The Subject uses an intrauterine device, diaphragm, NuvaRing, or additional contraceptive foam or gel for birth control.
• The Subject has:
• histology read as high-grade cervical intraepithelial neoplasia.
• cytology read as high-grade squamous intraepithelial lesion.
• cytology read as atypical glandular cytological abnormalities.
• cytology read as atypical squamous cells - cannot exclude high grade.

Where it is running

• Study site — Enterprise, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Colton, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Louisville, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Groton, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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