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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.

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

Page last updated: August 23, 2015

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