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

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.

Conditions

• Papillomavirus Infections

Interventions

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.

Sponsors & Collaborators

• Takeda

  lead INDUSTRY

Principal Investigators

• Medical Director · Takeda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• United States
• Canada
• Puerto Rico

Study Locations