Completed

An Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)

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What is being tested

Oxybutynin (Oxytrol, BAY839380)

Drug
Who is being recruted

Urogenital Diseases+8

+ Urinary Bladder Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 25, 2010

Actual date on which the first participant was enrolled.

With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

Official TitleAn Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)
NCT04534491
Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

855 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesUrinary Bladder, OveractiveLower Urinary Tract Symptoms

Criteria

6 inclusion criteria required to participate
Female
18 years of age or older
Not pregnant or suspected to be pregnant
Never trained or employed as a healthcare professional
Show More Criteria
6 exclusion criteria prevent from participating
Symptoms of blood in the urine not related to menses
Back pain and fever in conjunction with frequency or urgency and any of the following: dysuria, hematuria, or cloudy urine
Narrow-angle glaucoma
Pregnant (as determined by a urine pregnancy test among women of child bearing potential)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects decided to purchase Oxytrol.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stevenson Family Pharmacy

Saint Joseph, United StatesOpen Stevenson Family Pharmacy in Google Maps
CompletedOne Study Center