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Recruiting NCT05401032

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

Phase II Interventional BPH LUTS(Lower Urinary Tract Symptoms)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tamsulosin, 5-hidroxitriptophan.
Who it may be relevant to
Registry conditions: BPH, LUTS(Lower Urinary Tract Symptoms). Basic parameters: 50 years — 74 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.

Interventions

  • Drug Tamsulosin
    Oral medication, once a day for 6 months.
  • Drug 5-hidroxitriptophan
    Oral medication, 3 times a day for 6 months.

Primary outcome measures

  • International Prostate Symptom Score (IPSS) [Time frame: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)]
Secondary outcome measures (4)
  • Qmax [Time frame: Change from baseline to EOT (6-month)]
  • IIEF-5 [Time frame: Change from baseline to EOT (6-month)]
  • Prostate volume [Time frame: Change from baseline to EOT (6-month)]
  • question 8 of the IPSS [Time frame: Change from baseline to EOT (6-month)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Clinical Academic Center - Braga, Association (2CA-Braga) — Braga

Identifiers

NCT: NCT05401032 · TryptoBPH · 2024-519076-75-00 · 2021-000946-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗