RecruitingPhase 3NCT07184827

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in Women


Sponsor

TCM Biotech International Corp.

Enrollment

348 participants

Start Date

Oct 14, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called U101 for people with recurrent urinary tract infections in women. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGU101

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.

OTHERPlacebo

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.


Locations(13)

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chang Gung Memorial Hospital, Taipei Branch

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital (TSGH)

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkuo Branch

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07184827


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