Status:
RECRUITING
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Lead Sponsor:
TCM Biotech International Corp.
Conditions:
Recurrent Urinary Tract Infections in Women
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of U101 versus placebo in women with recurrent urinary tract infections (UTIs). The study will...
Eligibility Criteria
Inclusion
- Provide a signed informed consent form.
- Non-pregnant, non-nursing females ≥ 20 and \< 76 years old.
- Having a history of ≥ 2 UTI events during the preceding 6 months or ≥ 3 UTI events during the preceding 12 months (including any UTI event that occurs on the date of ICF signing). At least one of the previous UTI events must have microbiologic evidence (e.g., per the investigator's judgment based on urine culture results).
- The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.
- Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.
Exclusion
- Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.
- Women of childbearing potential who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period (use of spermicide is prohibited). Women of childbearing potential are defined as premenopausal females capable of becoming pregnant.
- Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin \> 1.5 x upper limit of normal (ULN).
- Serum creatinine \> 1.5 x ULN.
- Prothrombin time (PT) or INR \> 1.2 x ULN.
- Platelet counts \< 100,000/μL.
- Serum vitamin D level \< 11 ng/mL.
- HbA1c \> 8.0%.
- Positive test for hepatitis B (both HBsAg and HBeAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody).
- Symptoms suggestive of a systemic inflammatory response (fever \> 38℃ or WBC count \> 12,000) at the screening.
- A major functional or anatomical abnormality of the urogenital tract (e.g., renal cell carcinoma, outlet obstruction, etc.).
- Diagnosis of pelvic organ prolapse ≥ grade 2 (according to pelvic organ prolapse quantification POP-Q classification) without any treatment within 6 months of the screening visit.
- Diagnosis of complicated UTIs within 6 months of the screening visit.
- Residual urine volume \> 100 mL within a month of the screening visit.
- History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.
- Having any of the following procedures within a week of the screening: urinary catheterization (e.g., Foley catheter), ureteral stent, percutaneous nephrostomy, or cystostomy.
- Intravesical instillation of hyaluronic acid within 6 months of the screening visit.
- Treatment with pentosan polysulfate sodium (PPS) within 6 months of the screening visit.
- Use of antibiotic prophylaxis for rUTI within a month of the screening visit.
- Use of local hormone therapy (cream, gel, insert, ring, or tablets) in urogenital areas within a month of the screening.
- Any history of thrombocytopenia, hemophilia, or bladder cancer; history of endoscopy-confirmed gastrointestinal ulcers within 3 years prior to randomization.
- Active malignancy (under intensive cancer treatment or considered in progression) or a history of any malignancy involving the pelvic cavity within 5 years prior to randomization, with the exception of adequately treated basal cell carcinoma and cervical cancer in-situ. Subjects in stable condition will be evaluated and discussed individually with the investigator.
- Immunocompromised or history of organ transplant.
- History of allergies to pentosan polysulfate sodium.
- Having planned major surgery within 24 weeks after the study.
- Participation in any interventional clinical trial within 30 days of the screening visit.
- Other significant medical problem(s) or intercurrent acute illness(es) that in the opinion of the Investigators, would make participation in the study unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objective.
- Subjects who are illiterate.
- Subjects having a family history of macular degeneration or having been diagnosed with macular degeneration (except for those with asymptomatic age-related macular degeneration) .
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT07184827
Start Date
October 14 2020
End Date
July 31 2028
Last Update
September 22 2025
Active Locations (13)
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1
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
3
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
4
China Medical University Hospital
Taichung, Taiwan