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Terminated Phase 3 Interventional Results available

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

ClinicalTrials.gov ID: NCT04688931

Public ClinicalTrials.gov record NCT04688931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Study identification

NCT ID
NCT04688931
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
UroGen Pharma Ltd.
Industry
Enrollment
282 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 19, 2021 (Actual)
Primary completion
Mar 17, 2023 (Actual)
Completion
Mar 17, 2023 (Actual)
Last update posted
Jun 6, 2024

2021 – 2023

United States locations

U.S. sites
33
U.S. states
16
U.S. cities
33
Facility City State ZIP Site status
Arizona Institute of Urology, PLLC Tucson Arizona 85704 —
Loma Linda University Medical Center Loma Linda California 92350 —
Urology Group of Southern California Los Angeles California 90017 —
San Diego Clinical Trials San Diego California 92120 —
Providence Saint John's Health Center Santa Monica California 90404 —
Skyline Urology Sherman Oaks California 91411 —
University of Chicago Hospital Chicago Illinois 60637 —
Comprehensive Urologic Care Lake Barrington Illinois 60010 —
First Urology, PSC Jeffersonville Indiana 47130 —
Wichita Urology Group Wichita Kansas 67226 —
Regional Urology, LLC Shreveport Louisiana 71106 —
Chesapeake Urology Research Associates Baltimore Maryland 21204 —
Chesapeake Urology Research Associates Hanover Maryland 21076 —
Adult & Pediatric Urology, PC Omaha Nebraska 68114 —
Urology Center Las Vegas Nevada 89144 —
New Jersey Urology Bloomfield New Jersey 07003 —
New Jersey Urology Englewood New Jersey 07631 —
Garden State Urology Morristown New Jersey 07960 —
Albany Medical Center Albany New York 12208 —
Great Lakes Physician dba WNY Urology Associates Cheektowaga New York 14225 —
AccuMed Research Associates Garden City New York 11530 —
Manhattan Medical Research New York New York 10016 —
Stony Brook Cancer Center Stony Brook New York 11794 —
Associated Medical Professionals of NY, PLLC Syracuse New York 13210 —
UNC Chapel Hill Memorial Hospital Chapel Hill North Carolina 27599 —
Clinical Research Solutions Middleburg Heights Ohio 44130 —
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology Bala-Cynwyd Pennsylvania 19004 —
Penn State Health Milton S. Hershey Medical Center and College of Medicine Hershey Pennsylvania 17033 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
University of Pittsburgh Pittsburgh Pennsylvania 15237 —
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Urology San Antonio San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04688931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 6, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04688931 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →