Overview

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
Female
Summary
This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duramed Research
Criteria
Inclusion Criteria:

- Diagnosis of overactive bladder and incontinence for at least 6 months

- Using birth control or menopausal

- Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

- Pregnant or given birth in the last 6 months

- Three or more urinary tract infections a year

- Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis

- History of bladder cancer, ulcerative colitis or severe constipation

- Any contraindication to vaginal delivery systems