Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH
Clinical Academic Center (2CA-Braga)
70 participants
Dec 20, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria14
- 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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Interventions
Oral medication, once a day for 6 months.
Oral medication, 3 times a day for 6 months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05401032