Actively Recruiting
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in Preventing Uncomplicated Recurrent Urinary Tract Infections in Women
Led by TCM Biotech International Corp. · Updated on 2025-09-22
348
Participants Needed
13
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the drug U101 can prevent recurrent urinary tract infections (rUTIs) in women aged 20 to under 76 years who have a history of these infections. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the drug's effectiveness in reducing UTI recurrence, its safety, and its impact on quality of life during a 24-week treatment period. Participants are randomly assigned to receive either U101 or a placebo. The treatment involves taking one capsule orally three times a day for the first 8 weeks, then twice a day for the following 16 weeks. After completing the 24-week main study, participants may choose to join an open-label extension (OLE) for another 24 weeks to continue treatment or enter a safety follow-up period without treatment. During the study, participants will have checkups every 4 weeks and additional visits if UTI symptoms occur. Researchers will monitor UTI recurrence rates, quality of life measures like pain and daily activity interference, and safety through laboratory tests, vital signs, and physical exams. The main analysis will be done at the end of the 24-week treatment, with ongoing safety follow-up thereafter.
CONDITIONS
Brief 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...
- Signed informed consent form is provided.
- Female, not pregnant or nursing, aged 20 to under 76 years.
- History of at least 2 urinary tract infections in the last 6 months or 3 in the last 12 months, with at least one confirmed by urine culture.
- Negative urine culture before randomization.
- No symptoms or signs of urinary tract infection and negative urinalysis on the day of randomization.
You will not qualify if you...
- Pregnant, nursing, desire for pregnancy, or positive pregnancy test at screening.
- Women of childbearing potential unwilling or unable to use effective contraception throughout the study.
- Elevated liver enzymes or bilirubin above 1.5 times the normal limit.
- High serum creatinine over 1.5 times normal.
- Prolonged blood clotting times (PT or INR) over 1.2 times normal.
- Low platelet count below 100,000/µL.
- Very low vitamin D levels below 11 ng/mL.
- High HbA1c over 8.0%.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Signs of systemic infection like fever over 38°C or high white blood cell count at screening.
- Major anatomical or functional urogenital abnormalities.
- Pelvic organ prolapse grade 2 or higher without recent treatment.
- Complicated urinary tract infections within 6 months.
- High residual urine volume over 100 mL within one month.
- History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.
- Recent urinary procedures such as catheterization or stents within a week.
- Recent intravesical hyaluronic acid or pentosan polysulfate sodium treatment within 6 months.
- Antibiotic prophylaxis for rUTI within one month.
- Use of local hormone therapy in urogenital areas within one month.
- History of bleeding disorders, bladder cancer, or recent gastrointestinal ulcers.
- Active or recent pelvic malignancy within 5 years, except certain treated skin or cervical cancers.
- Immunocompromised status or organ transplant history.
- Allergy to pentosan polysulfate sodium.
- Planned major surgery during the study period.
- Participation in another interventional trial within 30 days.
- Other significant medical problems or acute illness deemed unsafe by investigators.
- Illiteracy.
- Family history or diagnosis of macular degeneration except asymptomatic age-related cases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants take U101 or placebo capsules orally three times per day for 8 weeks followed by twice per day for 16 weeks to prevent recurrent urinary tract infections.
Visits every 4 weeks during treatment period (approximately 6 visits) with additional special visits if UTI symptoms occur
Duration - 24 weeks
Participants may continue with an optional open-label extension program receiving U101 treatment again or enter a long-term follow-up period without treatment to collect additional safety and efficacy data.
2 visits at Week 8 and Week 24
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
P
Principal Investigator
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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