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A Safety Extension Study of DR-OXY-301

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ClinicalTrials.gov Identifier: NCT00782769
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Oxybutinyn Vaginal Ring 4mg Drug: Oxybutinyn Vaginal Ring 6mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxybutinyn Vaginal Ring 4mg
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 4mg
Other Name: DR-3001

Experimental: Oxybutinyn Vaginal Ring 6mg
inserted daily and replaced every 4 weeks
Drug: Oxybutinyn Vaginal Ring 6mg
Other Name: DR-3001




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782769


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

Responsible Party: Duramed Research
ClinicalTrials.gov Identifier: NCT00782769     History of Changes
Other Study ID Numbers: DR-OXY-302
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

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