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
1 other identifier
interventional
240
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 16, 2023
March 1, 2023
1.8 years
October 29, 2008
March 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Oxybutinyn Vaginal Ring 4mg
EXPERIMENTALinserted daily and replaced every 4 weeks
Oxybutinyn Vaginal Ring 6mg
EXPERIMENTALinserted daily and replaced every 4 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (35)
Duramed Investigational Site
Phoenix, Arizona, 85015, United States
Duramed Investigational Site
San Diego, California, 92103, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Duramed Investigational Site
Miami, Florida, 33143, United States
Duramed Investigational Site
Tampa, Florida, 33607, United States
Duramed Investigational Site
Augusta, Georgia, 30901, United States
Duramed Investigational Site
Savannah, Georgia, 31406, United States
Duramed Investigational Site
Boise, Idaho, 83712, United States
Duramed Investigational Site
Chicago, Illinois, 60661-3095, United States
Duramed Investigational Site
Wichita, Kansas, 67207, United States
Duramed Investigational Site
Louisville, Kentucky, 40291, United States
Duramed Investigational Site
Watertown, Massachusetts, 02472, United States
Duramed Investigational Site
Las Vegas, Nevada, 89030, United States
Duramed Investigational Site
Las Vegas, Nevada, 89109, United States
Duramed Investigational Site
Las Vegas, Nevada, 89128, United States
Duramed Investigational Site
Moorestown, New Jersey, 08057, United States
Duramed Investigational Site
Albuquerque, New Mexico, 87102, United States
Duramed Investigational Site
Port Jefferson, New York, 11777, United States
Duramed Investigational Site
New Bern, North Carolina, 28562, United States
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Duramed Investigational Site
Eugene, Oregon, 97401, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Pottstown, Pennsylvania, 19464, United States
Duramed Investigational Site
Columbia, South Carolina, 29201, United States
Duramed Investigational Site
Hilton Head Island, South Carolina, 29926, United States
Duramed Investigational Site
Jackson, Tennessee, 38305, United States
Duramed Investigational Site
Houston, Texas, 77024, United States
Duramed Investigational Site
Waco, Texas, 76712, United States
Duramed Investigational Site
Williston, Vermont, 05495, United States
Duramed Investigational Site
Norfolk, Virginia, 23507, United States
Duramed Investigational Site
Seattle, Washington, 98105, United States
Duramed Investigational Site
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duramed Research Protocol Chair
Duramed Research, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 16, 2023
Record last verified: 2023-03