A Safety Extension Study of DR-OXY-301 - Full Text View

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00782769

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: DR-3001	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder

Further study details as provided by Duramed Research:

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 [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DR-3001 4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
2: Experimental	Drug: DR-3001 6mg/day vaginal ring inserted vaginally and replaced every 4 weeks

Detailed Description:

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782769

Show 34 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Research Protocol Chair

Duramed Research, Inc

More Information

Responsible Party:	Duramed Research, Inc. ( Duramed Research, Inc. )
Study ID Numbers:	DR-OXY-302
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782769
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009