NCT00782769

A Safety Extension Study of DR-OXY-301

A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Oxybutinyn Vaginal Ring 4mg
DRUG	Oxybutinyn Vaginal Ring 6mg

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-10-31
• Last updated: 2023-03-16

Locations

35 sites across 1 country: United States