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

Sponsors

Lead Sponsor: Duramed Research

Source Teva Pharmaceutical Industries
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.

Overall Status Completed
Start Date 2008-09-01
Completion Date 2010-07-01
Primary Completion Date 2010-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
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
Enrollment 240
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oxybutinyn Vaginal Ring 4mg

Arm Group Label: Oxybutinyn Vaginal Ring 4mg

Other Name: DR-3001

Intervention Type: Drug

Intervention Name: Oxybutinyn Vaginal Ring 6mg

Arm Group Label: Oxybutinyn Vaginal Ring 6mg

Other Name: DR-3001

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Duramed Research Protocol Chair Study Chair Duramed Research, Inc
Location
Facility:
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
Location Countries

United States

Verification Date

2016-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Oxybutinyn Vaginal Ring 4mg

Type: Experimental

Description: inserted daily and replaced every 4 weeks

Label: Oxybutinyn Vaginal Ring 6mg

Type: Experimental

Description: inserted daily and replaced every 4 weeks

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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