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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.


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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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