Actively Recruiting
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Led by TCM Biotech International Corp. · Updated on 2025-09-22
348
Participants Needed
13
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide a signed informed consent form.
- Female, not pregnant or nursing, aged 20 to under 76 years.
- History of 2 or more UTI events in the last 6 months or 3 or more UTI events in the last 12 months, with at least one confirmed by urine culture.
- Last urine culture before randomization must be negative.
- Negative urinalysis and no UTI symptoms on the day of randomization.
You will not qualify if you...
- Pregnant, nursing, desiring pregnancy, or positive pregnancy test at screening.
- Women of childbearing potential unwilling or unable to use acceptable contraception during the study (no spermicide use).
- Elevated liver enzymes (AST, ALT) or bilirubin above 1.5 times normal.
- Elevated serum creatinine above 1.5 times normal.
- Prolonged blood clotting times (PT or INR above 1.2 times normal).
- Low platelet counts below 100,000/µL.
- Low serum vitamin D below 11 ng/mL.
- High HbA1c over 8.0%.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Signs of systemic inflammation such as fever over 38°C or high white blood cell count at screening.
- Major functional or anatomical urogenital abnormalities.
- Pelvic organ prolapse grade 2 or higher without recent treatment.
- Complicated UTIs within 6 months prior to screening.
- Residual urine volume over 100 mL within one month prior to screening.
- History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.
- Recent urinary catheterization or related procedures within one week prior to screening.
- Intravesical hyaluronic acid treatment within 6 months prior to screening.
- Pentosan polysulfate sodium treatment within 6 months prior to screening.
- Antibiotic prophylaxis for rUTI within one month prior to screening.
- Local hormone therapy in urogenital area within one month prior to screening.
- History of thrombocytopenia, hemophilia, bladder cancer, or recent gastrointestinal ulcers.
- Active or recent malignancy involving pelvic cavity within 5 years, except certain skin or cervical cancers.
- Immunocompromised state or organ transplant history.
- Allergy to pentosan polysulfate sodium.
- Planned major surgery within 24 weeks after study start.
- Participation in other interventional trials within 30 days before screening.
- Other significant medical issues or acute illnesses making participation unsafe.
- Illiteracy.
- Family history or diagnosis of macular degeneration except asymptomatic age-related types.
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Trial Site Locations
Total: 13 locations
1
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Active, Not Recruiting
3
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
Actively Recruiting
4
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
5
Chung Shan Medical University Hospital
Taichung, Taiwan
Actively Recruiting
6
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
7
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
8
Chang Gung Memorial Hospital, Taipei Branch
Taipei, Taiwan
Actively Recruiting
9
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
10
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
11
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
12
Tri-Service General Hospital (TSGH)
Taipei, Taiwan
Actively Recruiting
13
Chang Gung Memorial Hospital, Linkuo Branch
Taoyuan, Taiwan
Actively Recruiting
Research Team
E
Emily Ma Clinical Research Manager
CONTACT
P
Principal Investigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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