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.

Bayer

Status and phase

Completed

Phase 3

Conditions

Overactive Bladder

Treatments

Drug: Oxybutynin (Oxytrol, BAY839380)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04534491

18165

Details and patient eligibility

About

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.

Enrollment

855 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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