A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

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

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Key information

Conditions

Urinary Incontinence, Urge Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

SNBL Clinical Pharmacology Center, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxybutynin

Drug

low dose oxybutynin administered daily

Primary outcomes

Number of micturations and incontinence episodes.

Time frame: Two weeks pretreatment and three weeks on treatment

Sponsors and collaborators

Lead sponsor

FemmePharma Global Healthcare, Inc.

Industry

Registry information

Official study title

An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence

Acronym: FP1097-002

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 9, 2008
Registry last updated: Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed