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Study identifier: NCT07184827 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Recurrent Urinary Tract Infections in Women  ·  Sponsor: TCM Biotech International Corp.

PhasePhase 3
Planned participants348
Who can joinFemale, 20 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Emily Ma Clinical Research Manager  ·  +886-2-2697-2628  ·  emilyma@tcmbio.com

Principal Investigator

Always discuss trial participation with your own doctor first.

Locations (13)

Chang Gung Memorial Hospital, Kaohsiung BranchKaohsiung City, TaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanActive Not Recruiting
Taipei Tzu Chi HospitalNew Taipei City, TaiwanRecruiting
China Medical University HospitalTaichung, TaiwanRecruiting
Chung Shan Medical University HospitalTaichung, TaiwanRecruiting
Taichung Veterans General HospitalTaichung, TaiwanRecruiting
National Cheng Kung University HospitalTainan, TaiwanRecruiting
Chang Gung Memorial Hospital, Taipei BranchTaipei, TaiwanRecruiting
National Taiwan University HospitalTaipei, TaiwanRecruiting
Taipei Medical University HospitalTaipei, TaiwanRecruiting
Taipei Veterans General HospitalTaipei, TaiwanRecruiting
Tri-Service General Hospital (TSGH)Taipei, TaiwanRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07184827