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A Safety Extension Study of DR-OXY-301

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duramed Research
ClinicalTrials.gov Identifier:
NCT00782769
First received: October 29, 2008
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ]

Enrollment: 240
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Experimental: 2 Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks

  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 35 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc
  More Information

No publications provided

Responsible Party: Duramed Research
ClinicalTrials.gov Identifier: NCT00782769     History of Changes
Other Study ID Numbers: DR-OXY-302
Study First Received: October 29, 2008
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013