Overactive Bladder
Conditions
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.
Interventions
DRUGOxybutinyn Vaginal Ring 4mg
DRUGOxybutinyn Vaginal Ring 6mg
Sponsors
Duramed Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed