Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.

NCT ID: NCT04534491

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 855 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-25
• Study Completion Date: 2011-06-22

Brief Summary

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxytrol

Subjects decided to purchase Oxytrol.

Group Type: EXPERIMENTAL

Oxybutynin (Oxytrol, BAY839380)

Intervention Type: DRUG

Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)

Interventions

Oxybutynin (Oxytrol, BAY839380)

Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female
• 18 years of age or older
• Not pregnant or suspected to be pregnant
• Never trained or employed as a healthcare professional
• Neither the subject nor anyone in their household worked for a pharmaceutical company, a pharmacy, a managed care or health insurance company, a healthcare practice, or as a healthcare professional
• Had not participated in any market research study, product label study or clinical trial in the past 12 months

Exclusion Criteria

• 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)
• Breastfeeding
• Known allergy to oxybutynin

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Stevenson Family Pharmacy

Saint Joseph, Missouri, United States

Countries

United States

Other Identifiers

18165

Identifier Type: -

Identifier Source: org_study_id