CLINICAL TRIALS PROFILE FOR OXYTROL FOR WOMEN

505(b)(2) Clinical Trials for Oxytrol For Women

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT04534491 ↗	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.	Completed	Bayer	Phase 3	2010-05-25	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.

All Clinical Trials for Oxytrol For Women

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224016 ↗	Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
NCT00224029 ↗	A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition	Completed	Watson Pharmaceuticals	Phase 4	2004-12-01	This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
NCT00224146 ↗	Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder	Completed	Watson Pharmaceuticals	Phase 4	2004-05-01	This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

Clinical Trial Conditions for Oxytrol For Women

Condition Name

Condition Name for Oxytrol For Women
Intervention	Trials
Overactive Bladder	4
Detrusor Hyperreflexia	2
Urinary Bladder Diseases	1

Condition MeSH

Condition MeSH for Oxytrol For Women
Intervention	Trials
Urinary Bladder, Overactive	4
Urinary Incontinence	2
Enuresis	2

Clinical Trial Locations for Oxytrol For Women

Trials by Country

Trials by Country for Oxytrol For Women
Location	Trials
United States	66
Canada	4

Trials by US State

Trials by US State for Oxytrol For Women
Location	Trials
Texas	5
North Carolina	4
New York	4
Georgia	3
Missouri	3

Clinical Trial Progress for Oxytrol For Women

Clinical Trial Phase

Clinical Trial Phase for Oxytrol For Women
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Oxytrol For Women
Clinical Trial Phase	Trials
Completed	6
Unknown status	1

Clinical Trial Sponsors for Oxytrol For Women

Sponsor Name

Sponsor Name for Oxytrol For Women
Sponsor	Trials
Watson Pharmaceuticals	3
Ottawa General hospital, Ottawa University, Ottawa, Ontario, Canada	1
Jewish General Hospital	1

Sponsor Type

Sponsor Type for Oxytrol For Women
Sponsor	Trials
Industry	5
Other	4

OXYTROL FOR WOMEN: Clinical Trials, Market Analysis, and Projections

Introduction to OXYTROL FOR WOMEN

OXYTROL FOR WOMEN, developed by Merck Consumer Care, is a groundbreaking over-the-counter (OTC) treatment for overactive bladder (OAB) in women. This transdermal system delivers 3.9 mg of oxybutynin per day, providing continuous relief for four days and nights.

Clinical Trials and FDA Approval

The FDA approval of OXYTROL FOR WOMEN on January 25, 2013, was based on several well-designed studies. These studies demonstrated that women could correctly recognize OAB symptoms, understand key safety messages on the label, and appropriately use the product in an unsupervised setting[1][2].

One notable study, the Actual Use Study (CONTROL), was conducted under simulated OTC conditions. This open-label, single-arm, multicenter study provided uncontrolled safety data from women using the product. The primary endpoint was the proportion of verified users who did not stop use when they developed new or worsening symptoms, which had a prespecified threshold of less than 5%[4].

Additionally, a label comprehension study and self-selection studies were conducted to refine the product label, ensuring that women could safely and effectively use OXYTROL FOR WOMEN without medical supervision[4].

Mechanism of Action and Usage

OXYTROL FOR WOMEN works by delivering oxybutynin, an active ingredient that has been used to treat OAB for over 30 years. The patch helps to relax the bladder muscle, reducing the urgency, frequency, and number of accidents associated with overactive bladder. It is applied to the abdomen, hip, or buttock once every four days and can be worn during everyday activities, including showering or exercising[1][2].

Market Analysis

The overactive bladder market is expected to grow significantly over the coming years. According to DelveInsight, the market is projected to grow at a considerable CAGR from 2019 to 2032. This growth is driven by the increasing prevalence of OAB, particularly among women, who are affected at a rate 1.5 to 2 times higher than men[3].

OXYTROL FOR WOMEN addresses a significant unmet need for over 20 million American women suffering from OAB. Despite the treatable nature of the condition, more than 80% of women with OAB do not seek treatment. The availability of OXYTROL FOR WOMEN as an OTC option has provided these women with a convenient and effective treatment choice[1].

Competitive Landscape

The overactive bladder market is competitive, with several major pharmaceutical companies involved. Key players include Urovant Sciences, Bayer, Taiho Pharmaceutical, Astellas Pharma Inc, Kyorin Pharmaceutical, Novartis, and Pfizer. These companies are developing novel treatments for OAB, which will continue to shape the market landscape in the coming years[3].

Projections and Future Outlook

Given the growing demand for OAB treatments and the unique position of OXYTROL FOR WOMEN as the first and only OTC treatment for women, the product is expected to maintain a strong market presence. The convenience and efficacy of the transdermal system, combined with lifestyle modifications such as a daily bathroom schedule, fluid intake management, and bladder muscle strengthening, make it an attractive option for women seeking to manage their OAB symptoms[2].

Lifestyle Modifications and Treatment Efficacy

In addition to using OXYTROL FOR WOMEN, women can achieve better control over their OAB symptoms by implementing lifestyle changes. These include following a daily bathroom schedule, managing fluid intake, and strengthening bladder muscles. Maintaining a healthy weight is also crucial, as excess weight can increase pressure on the bladder and exacerbate OAB symptoms[2].

Market Growth Drivers

The growth of the OAB market is driven by several factors, including the increasing prevalence of the condition, especially among women, and the development of new treatments. The availability of OTC options like OXYTROL FOR WOMEN has increased access to treatment, contributing to market growth[3].

Key Takeaways

• First OTC Treatment: OXYTROL FOR WOMEN is the first and only over-the-counter treatment for overactive bladder in women.
• Clinical Trials: FDA approval was based on well-designed studies demonstrating safe and effective use in an unsupervised setting.
• Market Growth: The OAB market is expected to grow significantly, driven by increasing prevalence and new treatment developments.
• Competitive Landscape: Major pharmaceutical companies are actively developing new OAB treatments.
• Lifestyle Modifications: Combining OXYTROL FOR WOMEN with lifestyle changes can enhance treatment efficacy.

FAQs

Q: What is OXYTROL FOR WOMEN, and how does it work?

A: OXYTROL FOR WOMEN is an over-the-counter transdermal system that delivers 3.9 mg of oxybutynin per day to treat overactive bladder in women. It works by relaxing the bladder muscle to reduce urgency, frequency, and accidents.

Q: Who is eligible to use OXYTROL FOR WOMEN?

A: OXYTROL FOR WOMEN is approved for use in women with overactive bladder. However, it is not recommended for women with certain conditions such as glaucoma, pregnancy, breastfeeding, or allergies to oxybutynin.

Q: How often is the OXYTROL FOR WOMEN patch applied?

A: The OXYTROL FOR WOMEN patch is applied once every four days to the abdomen, hip, or buttock.

Q: Can OXYTROL FOR WOMEN be used during everyday activities?

A: Yes, the patch can be worn during everyday activities, including showering or exercising.

Q: What lifestyle modifications can enhance the efficacy of OXYTROL FOR WOMEN?

A: Lifestyle modifications such as following a daily bathroom schedule, managing fluid intake, strengthening bladder muscles, and maintaining a healthy weight can enhance the efficacy of OXYTROL FOR WOMEN.

Sources

1. Merck Press Release: FDA Approves OXYTROL® FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women.
2. UroToday: OXYTROL® FOR WOMEN, the first over-the-counter treatment for overactive bladder in women now available nationwide.
3. GlobeNewswire: Overactive Bladder Market to Grow Rapidly at a Considerable CAGR During the Forecast Period 2023-2032 - DelveInsight.
4. FDA Documents: 202211s000 - accessdata.fda.gov.
5. FDA Documents: 202211s000 - accessdata.fda.gov.