Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04534491 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 855
- Enrollment target
NCT04534491: Completed Phase 3 study, sponsored by Bayer.
NCT04534491 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 855 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534491, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 855 participants
- Enrollment target
Study 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.
Primary Outcome
For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to conti
Interventions
- DRUG Oxybutynin (Oxytrol, BAY839380)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 855 participants |
| Start Date | 2010-05-25 |
| Est. Completion | 2011-06-22 |
| Phase | Phase 3 |
What the finished NCT04534491 record still lists
NCT04534491 is an interventional study that assigns participants to a tested intervention. The registered 855 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 1 intervention - of which Oxybutynin (Oxytrol, BAY839380) is the first listed.
NCT04534491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534491 about?
NCT04534491 is a clinical study titled "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.". 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 s...
What is the current status of trial NCT04534491?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 855 participants. The study started on 2010-05-25. Estimated completion is 2011-06-22.
What interventions are being tested in trial NCT04534491?
The interventions under investigation include: Oxybutynin (Oxytrol, BAY839380) (DRUG).
Who is sponsoring clinical trial NCT04534491?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534491's enrollment target sits among peer trials
855 384th of 2000 higher than 1,617 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05108896 · 855 participants · NA
Aspiration in Acute Respiratory Failure Survivors 2
- NCT06231485 · 856 participants · NA
Socialization To Enrich Participation & Support Sexuality for Young People With I/DD
- NCT07005102 · 854 participants · Phase 2
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
- NCT07290491 · 854 participants · Phase 3
Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI