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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• cervical carcinoma of any type.

• apparent endocervical involvement.

• high-grade vulvar intraepithelial neoplasia.

• high-grade vaginal intraepithelial neoplasia.

• If the limits of a cervical lesion cannot be readily visualized.

• If the limits of the transformation zone cannot be readily visualized.

• The subject has clinical evidence of a vaginal infection or sexually transmitted infection, other than cervical human papillomavirus infection at the Study Day 1 visit.

• The Subject has had a cervical biopsy within 1 month prior to the screening visit.

• The Subject has had any previous ablative or surgical treatment of the cervix within 3 months prior to the screening visit;

• The Subject has a history of alcoholism or substance abuse within 1 year or has current alcohol or substance abuse as assessed by the investigator.

• The Subject has tested positive for human immunodeficiency virus at the screening visit or has evidence of any other immunosuppressive disease.