A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Information source: FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence, Urge
Intervention: oxybutynin (Drug); oxybutynin (Drug); oxybutynin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: FemmePharma Global Healthcare, Inc. Official(s) and/or principal investigator(s): Peter K. Mays, Ph.D., Study Director, Affiliation: FemmePharma Global Healthcare, Inc.
Summary
The purpose of this study is to determine the safety of three doses of oxybutynin for the
treatment of urge urinary incontinence.
Clinical Details
Official title: An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of micturations and incontinence episodes.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Females 18 to 75 years of age
- Has reported symptoms of urge urinary incontinence/overactive bladder
Exclusion Criteria:
- Is pregnant or lactating
- Has had lower urinary tract surgery within 6 months prior to Screening
- Has a history of urinary retention
Locations and Contacts
SNBL Clinical Pharmacology Center, Baltimore, Maryland 21201, United States
Advanced Biomedical Research, Hackensack, New Jersey 07601, United States
Additional Information
Starting date: July 2007
Last updated: October 13, 2009
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