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Sponsored by: |
Duramed Research |
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Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00782769 |
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 |
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Overactive Bladder |
Drug: DR-3001 |
Phase III |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
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2: Experimental |
Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Chair: | Duramed Research Protocol Chair | Duramed Research, Inc |
Responsible Party: | Duramed Research, Inc. ( Duramed Research, Inc. ) |
Study ID Numbers: | DR-OXY-302 |
Study First Received: | October 29, 2008 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00782769 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases Urinary Bladder Diseases |
Signs and Symptoms Urological Manifestations Urinary Bladder, Overactive Urologic Diseases Urinary Bladder Diseases |