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

RecruitingPhase 2Ages 50 Years - 74 YearsMaleClinical Academic Center (2CA-Braga)
NCT05401032 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies. Oxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition. This is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). El

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tamsulosin
  • 5-hidroxitriptophan
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Where

1 site
Clinical Academic Center - Braga, Association (2CA-Braga)
Braga, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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