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A Safety Extension Study of DR-OXY-301

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxybutinyn Vaginal Ring 4mg
Oxybutinyn Vaginal Ring 6mg
Sponsored by
Duramed Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site
  • Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxybutinyn Vaginal Ring 4mg

Oxybutinyn Vaginal Ring 6mg

Arm Description

inserted daily and replaced every 4 weeks

inserted daily and replaced every 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 29, 2008
Last Updated
March 14, 2023
Sponsor
Duramed Research
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1. Study Identification

Unique Protocol Identification Number
NCT00782769
Brief Title
A Safety Extension Study of DR-OXY-301
Official Title
A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duramed Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxybutinyn Vaginal Ring 4mg
Arm Type
Experimental
Arm Description
inserted daily and replaced every 4 weeks
Arm Title
Oxybutinyn Vaginal Ring 6mg
Arm Type
Experimental
Arm Description
inserted daily and replaced every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Oxybutinyn Vaginal Ring 4mg
Other Intervention Name(s)
DR-3001
Intervention Type
Drug
Intervention Name(s)
Oxybutinyn Vaginal Ring 6mg
Other Intervention Name(s)
DR-3001
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duramed Research Protocol Chair
Organizational Affiliation
Duramed Research, Inc
Official's Role
Study Chair
Facility Information:
Facility Name
Duramed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Duramed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Duramed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Duramed Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Duramed Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Duramed Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Duramed Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Duramed Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60661-3095
Country
United States
Facility Name
Duramed Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Duramed Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Duramed Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Duramed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Duramed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Duramed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duramed Investigational Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Duramed Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Duramed Investigational Site
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Duramed Investigational Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Duramed Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Duramed Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Duramed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Duramed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Duramed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Duramed Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Duramed Investigational Site
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Duramed Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Duramed Investigational Site
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Duramed Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Duramed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Duramed Investigational Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Duramed Investigational Site
City
Williston
State/Province
Vermont
ZIP/Postal Code
05495
Country
United States
Facility Name
Duramed Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Duramed Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Duramed Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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A Safety Extension Study of DR-OXY-301

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