Evaluating Tryptophan for Treating BPH Symptoms

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

This study is testing whether Tryptophan can help men with BPH symptoms feel better without the sexual side effects that come with usual treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 50 Years to 74 Years
• Sex: Male
• Sponsor: Clinical Academic Center (2CA-Braga) (Academic / other)
• Locations: 1 site (Braga)
• Trial ID: NCT05401032 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of Tryptophan (5-HTP) in men with benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS). The study will randomly assign eligible participants to receive either Tamsulosin or 5-HTP to compare their effects on symptom relief. The trial is designed to explore a novel pharmacological approach that may improve symptoms without the sexual side effects commonly associated with current BPH treatments. Conducted at the Hospital de Braga, this single-center trial will provide insights into alternative therapies for BPH.

Who should consider this trial

Good fit: Ideal candidates are men aged 50 to 75 with diagnosed BPH and LUTS who are eligible for Tamsulosin treatment.

Not a fit: Patients with severe urinary retention, active urinary tract infections, or a history of prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for men suffering from BPH that minimizes side effects.

How similar studies have performed: While the use of Tryptophan for BPH is a novel approach, similar studies exploring alternative treatments for LUTS have shown promise.

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.

Where this trial is running

Braga

• Clinical Academic Center - Braga, Association (2CA-Braga) — Braga, Portugal (Recruiting)

Study contacts

• Principal investigator: Emanuel Dias — Hospital de Braga
• Study coordinator: Mónica Gonçalves

Conditions BPH; LUTS; 5-HTP; Oxitriptan; Tamsulosin