Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women. (NCT00312286) | Clinical Trial Compass
TerminatedPhase 2
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.
Stopped: Lack of efficacy
United States538 participantsStarted 2006-04
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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 th…
What they're measuring
1
Time to clearance of high-risk human papillomavirus infection.