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Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women

NCT07184827 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-09-22

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \< 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are:

* Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment?
* Will the Quality of Life be improved during the 24-week treatment?
* What medical problems do participants have when taking drug U101?

Researchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI.

Participants will:

* Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks.
* Visit the site once every 4 weeks for checkups and tests during the main study.
* be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study.
* Visit the site when the suspected UTI occurred during the main study or the extension study.

Conditions

  • Recurrent Urinary Tract Infections in Women

Interventions

DRUG

U101

One capsule (100 mg) of U101 will be administered orally three times per day (TID) for 8 weeks followed by one capsule of U101 twice per day (BID) for 16 weeks.

OTHER

Placebo

One capsule of Placebo will be administered orally three times per day (TID) for 8 weeks followed by one capsule of placebo twice per day (BID) for 16 weeks.

Sponsors & Collaborators

  • TCM Biotech International Corp.

    lead INDUSTRY

Principal Investigators

  • En Meng, MD · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2028-06-30
Completion
2028-07-31

Countries

  • Taiwan

Study Locations

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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 NCT07184827 on ClinicalTrials.gov