A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

Key facts

Study ID

NCT00685113

Run by

Duramed Research

People needed

1104

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2016-07-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months
• Able to distinguish between stress and urge incontinence
• During the Screening Period able to demonstrate the presence of overactive bladder with urge incontinence based on diary entries
• Others as dictated by FDA-approved protocol

You may not qualify if…

• Stress incontinence, continuous incontinence or overflow urinary incontinence
• Chronic illness, neurological dysfunction or injury that could cause incontinence
• Pregnant, breastfeeding, or gave birth in the last 6 months
• Others as dictated by FDA-approved protocol

Where it is running

• Duramed Investigational Site — Mobile, Alabama, United States
• Duramed Investigational Site — Montgomery, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Little Rock, Arkansas, United States
• Duramed Investigational Site — Encinitas, California, United States
• Duramed Investigational Site — Los Angeles, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Colorado Springs, Colorado, United States
• Duramed Investigational Site — Denver, Colorado, United States
• Duramed Investigational Site — Danbury, Connecticut, United States
• Duramed Investigational Site — Milford, Connecticut, United States
• Duramed Investigational Site — New London, Connecticut, United States
• Duramed Investigational Site — Aventura, Florida, United States
• Duramed Investigational Site — Gainesville, Florida, United States
• Duramed Investigational Site — Jacksonville, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — New Port Richey, Florida, United States
• Duramed Investigational Site — Tampa, Florida, United States
• Duramed Investigational Site — West Palm Beach, Florida, United States
• Duramed Investigational Site — West Palm Beach, Florida, United States
• Duramed Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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