Status:
TERMINATED
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Lead Sponsor:
Takeda
Conditions:
Papillomavirus Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief 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.
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% ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT00312286
Start Date
April 1 2006
End Date
June 1 2008
Last Update
September 23 2016
Active Locations (93)
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1
Birmingham, Alabama, United States
2
Enterprise, Alabama, United States
3
Huntsville, Alabama, United States
4
Montgomery, Alabama, United States