A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

Phase 2

Completed

• Conditions: Urinary Incontinence, Urge
• Interventions: Drug: oxybutynin

• Registration Number: NCT00749632
• Lead Sponsor: FemmePharma Global Healthcare, Inc.

Brief Summary

The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-10
• Disposition First Submitted: 2009-10-13
• Disposition First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Disposition First Posted: 2009-10-15
• Last Update Posted: 2009-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Females 18 to 75 years of age
• Has reported symptoms of urge urinary incontinence/overactive bladder

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Exclusion Criteria

• Is pregnant or lactating
• Has had lower urinary tract surgery within 6 months prior to Screening
• Has a history of urinary retention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	oxybutynin	-
1	oxybutynin	-
2	oxybutynin	-

Primary Outcome Measures

Name	Time	Method
Number of micturations and incontinence episodes.	Two weeks pretreatment and three weeks on treatment

Trial Locations

Locations (2)

SNBL Clinical Pharmacology Center; 🇺🇸 Baltimore, Maryland, United States

Advanced Biomedical Research; 🇺🇸 Hackensack, New Jersey, United States