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URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

NCT04211831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-04-20

Study results available
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Summary

This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.

Conditions

  • Overactive Bladder With Urge Urinary Incontinence

Interventions

DRUG

URO-902

intradetrusor injection

DRUG

Placebo

intradetrusor injection

Sponsors & Collaborators

  • Urovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Hanh Badger, PharmD · Urovant Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2021-11-18
Completion
2022-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211831 on ClinicalTrials.gov