Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.

Launched by CLINICAL ACADEMIC CENTER (2CA-BRAGA) · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for men with benign prostatic hyperplasia (BPH), a condition that causes problems with urination. The trial aims to see how safe and effective a substance called 5-hydroxytryptophan (5-HTP) is for relieving symptoms related to BPH. This treatment is being compared to a commonly used medication called tamsulosin. Researchers hope that 5-HTP will improve urinary symptoms without causing the sexual side effects that some current medications do.

To be eligible for this study, participants must be male, between 50 and 75 years old, and diagnosed with BPH and lower urinary tract symptoms (LUTS). They should also have a prostate volume of at least 30 cm³. Participants in the study will be randomly assigned to take either tamsulosin or 5-HTP for six months. Throughout the trial, participants will be closely monitored for any changes in their symptoms and overall health. This could be a great opportunity for men struggling with BPH to explore a potential new treatment option.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.