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A Safety Extension Study of DR-OXY-301

NCT ID: NCT00782769

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxybutinyn Vaginal Ring 4mg

inserted daily and replaced every 4 weeks

Group Type EXPERIMENTAL

Oxybutinyn Vaginal Ring 4mg

Intervention Type DRUG

Oxybutinyn Vaginal Ring 6mg

inserted daily and replaced every 4 weeks

Group Type EXPERIMENTAL

Oxybutinyn Vaginal Ring 6mg

Intervention Type DRUG

Interventions

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Oxybutinyn Vaginal Ring 4mg

Intervention Type DRUG

Oxybutinyn Vaginal Ring 6mg

Intervention Type DRUG

Other Intervention Names

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DR-3001 DR-3001

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duramed Research Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc

Locations

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Duramed Investigational Site

Phoenix, Arizona, United States

Site Status

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San Diego, California, United States

Site Status

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San Diego, California, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Watertown, Massachusetts, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Moorestown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Port Jefferson, New York, United States

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New Bern, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Hilton Head Island, South Carolina, United States

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Jackson, Tennessee, United States

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Houston, Texas, United States

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Waco, Texas, United States

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Williston, Vermont, United States

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Norfolk, Virginia, United States

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Duramed Investigational Site

Seattle, Washington, United States

Site Status

Duramed Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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DR-OXY-302

Identifier Type: -

Identifier Source: org_study_id

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