A Phase 3 interventional study of Oxybutinyn Vaginal Ring 4mg and Oxybutinyn Vaginal Ring 6mg in Overactive Bladder, sponsored by Duramed Research. Completed at 35 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Duramed Research · Phase 3, Interventional, and Treatment
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 240 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Duramed Research is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 4mg
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 6mg
Also known as: DR-3001
Also known as: DR-3001
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
Time frame: Duration of Study
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Duramed Research