A Safety Extension Study of DR-OXY-301
Completed · Phase 3
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT00782769
- Run by
- Duramed Research
- People needed
- 240
- Starts
- 2008-09-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2023-03-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Duramed Investigational Site — Phoenix, Arizona, United States
- Duramed Investigational Site — San Diego, California, United States
- Duramed Investigational Site — San Diego, California, United States
- Duramed Investigational Site — Miami, Florida, United States
- Duramed Investigational Site — Tampa, Florida, United States
- Duramed Investigational Site — Augusta, Georgia, United States
- Duramed Investigational Site — Savannah, Georgia, United States
- Duramed Investigational Site — Boise, Idaho, United States
- Duramed Investigational Site — Chicago, Illinois, United States
- Duramed Investigational Site — Wichita, Kansas, United States
- Duramed Investigational Site — Louisville, Kentucky, United States
- Duramed Investigational Site — Watertown, Massachusetts, United States
- Duramed Investigational Site — Las Vegas, Nevada, United States
- Duramed Investigational Site — Las Vegas, Nevada, United States
- Duramed Investigational Site — Las Vegas, Nevada, United States
- Duramed Investigational Site — Moorestown, New Jersey, United States
- Duramed Investigational Site — Albuquerque, New Mexico, United States
- Duramed Investigational Site — Port Jefferson, New York, United States
- Duramed Investigational Site — New Bern, North Carolina, United States
- Duramed Investigational Site — Oklahoma City, Oklahoma, United States
- Duramed Investigational Site — Eugene, Oregon, United States
- Duramed Investigational Site — Medford, Oregon, United States
- Duramed Investigational Site — Philadelphia, Pennsylvania, United States
- Duramed Investigational Site — Philadelphia, Pennsylvania, United States
- Duramed Investigational Site — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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