NCT00685113

A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of DR-3001 Versus Placebo in Women With Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,104 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	DR-3001	4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
DRUG	DR-3001	6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
DRUG	Placebo	Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-05-28
• Last updated: 2016-07-20

Locations

84 sites across 2 countries: United States, Canada