Trial Condition(s):

Overactive Bladder

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 Identifier:

18165

ClinicalTrials.gov Identifier:

NCT04534491

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
855
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Oxytrol® for Women (Oxybutynin, BAY839380)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Stevenson Family Pharmacy

St. Joseph, United States, 64504

Status
Completed
 

Trial Design