Status:
RECRUITING
Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
Lead Sponsor:
Clinical Academic Center (2CA-Braga)
Conditions:
BPH
LUTS(Lower Urinary Tract Symptoms)
Eligibility:
MALE
50-74 years
Phase:
PHASE2
Brief Summary
Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adren...
Eligibility Criteria
Inclusion
- Written informed consent;
- Male patients with BPH for which tamsulosin is the therapeutic option per SoC;
- Aged ≥50 and less than 75 years old;
- With prostate volume ≥30 cm3 by TRUS;
- Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.
Exclusion
- Patients with post-void bladder residual volume ≥250 ml;
- Patients with intravesical obstruction from any cause other than BPH;
- History of any procedure considered an intervention for BPH;
- Patients with active urinary tract infection;
- History of recurrent urinary tract infections;
- Current prostatitis or diagnosis of chronic prostatitis;
- History of prostate or invasive bladder cancer;
- Use of 5 α-reductase inhibitors within 6 months;
- Phytotherapy within 2 weeks before entry;
- Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;
- Patients with acute or chronic kidney failure;
- Patients with diagnosed or suspicion of intolerance to lactose;
- Patients submitted to general anesthesia in the past 4 weeks;
- Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.
Key Trial Info
Start Date :
December 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05401032
Start Date
December 20 2024
End Date
December 31 2026
Last Update
January 6 2025
Active Locations (1)
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1
Clinical Academic Center - Braga, Association (2CA-Braga)
Braga, Portugal, 4710-243