Evaluating Tryptophan for Treating BPH Symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Emanuel Dias — Hospital de Braga
• Study coordinator: Mónica Gonçalves
• Email: 2ca@ccabraga.org
• Phone: +351 253 027 249

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ultrasound imaging to assess lower urinary tract symptoms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.