A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities

Trial Information

A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities

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% of sexually active women will become infected during their lifetime with
human papillomavirus and 50% of these infections will be due to high-risk human
papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a
very substantial number of women are left with uncertainty regarding whether their infection
will clear spontaneously or progress to cancer.

Subjects participating in this study were required to visit the clinic for approximately 15
or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of
participation in this study was approximately 27 months.