NCT00312286

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

A Randomized, Placebo-Controlled Phase II Study of Multiple Dosing Regimens of Intravaginally Administered 851B Gel for the Treatment of Cervical High Risk HPV Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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% 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.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
DRUG	851B	851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
DRUG	851B	851B 1.5% formulation, gel, topically, twice a week for 1 cycle.
DRUG	851B	851B 1.5% formulation, gel, topically, twice a week for 2 cycles.
DRUG	851B	851B 3.0% formulation, gel, topically, once a week for 1 cycle.
DRUG	851B	851B 3.0% formulation, gel, topically, once a week for 2 cycles.
DRUG	851B	851B 3.0% formulation, gel, topically, twice a week for 1 cycle.
DRUG	851B	851B 3.0% formulation, gel, topically, twice a week for 2 cycles.
DRUG	851B	851B placebo-matching gel, topically, once a week for 1 cycle.
DRUG	851B	851B placebo-matching gel, topically, twice a week for 1 cycle.
DRUG	851B	851B placebo-matching gel, topically, once a week for 2 cycles.
DRUG	851B	851B placebo-matching gel, topically, twice a week for 2 cycles.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-04-10
• Last updated: 2016-09-23

Locations

93 sites across 3 countries: United States, Canada, Puerto Rico