A Safety Extension Study of DR-OXY-301
Phase 3
Completed
- Conditions
- Overactive Bladder
- Interventions
- Drug: Oxybutinyn Vaginal Ring 4mgDrug: Oxybutinyn Vaginal Ring 6mg
- Registration Number
- NCT00782769
- Lead Sponsor
- Duramed Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
Inclusion Criteria
- Completed the 12 weeks of treatment in the DR-OXY-301 study
- Willing to limit medications for overactive bladder to investigational product only
- Able to understand and complete all study procedures including the required diary
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxybutinyn Vaginal Ring 4mg Oxybutinyn Vaginal Ring 4mg inserted daily and replaced every 4 weeks Oxybutinyn Vaginal Ring 6mg Oxybutinyn Vaginal Ring 6mg inserted daily and replaced every 4 weeks
- Primary Outcome Measures
Name Time Method Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported Duration of Study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Tacoma, Washington, United States