A Safety Extension Study of DR-OXY-301

March 14, 2023 updated by: Duramed Research

A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Duramed Investigational Site
    • California
      • San Diego, California, United States, 92108
        • Duramed Investigational Site
      • San Diego, California, United States, 92103
        • Duramed Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • Duramed Investigational Site
      • Tampa, Florida, United States, 33607
        • Duramed Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Duramed Investigational Site
      • Savannah, Georgia, United States, 31406
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Duramed Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60661-3095
        • Duramed Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Duramed Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Duramed Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Duramed Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Duramed Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Duramed Investigational Site
      • Las Vegas, Nevada, United States, 89030
        • Duramed Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Duramed Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Duramed Investigational Site
    • New York
      • Port Jefferson, New York, United States, 11777
        • Duramed Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Duramed Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Duramed Investigational Site
      • Medford, Oregon, United States, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
      • Pottstown, Pennsylvania, United States, 19464
        • Duramed Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
      • Hilton Head Island, South Carolina, United States, 29926
        • Duramed Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Duramed Investigational Site
    • Texas
      • Houston, Texas, United States, 77024
        • Duramed Investigational Site
      • Waco, Texas, United States, 76712
        • Duramed Investigational Site
    • Vermont
      • Williston, Vermont, United States, 05495
        • Duramed Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxybutinyn Vaginal Ring 4mg
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 4mg
Other Names:
  • DR-3001
Experimental: Oxybutinyn Vaginal Ring 6mg
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 6mg
Other Names:
  • DR-3001

What is the study measuring?

Primary Outcome Measures

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
Time Frame: Duration of Study
Duration of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-OXY-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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