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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Academic Center (2CA-Braga)
• Treatments: Tamsulosin

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; TryptoBPH Version 1.4 (December 6th, 2021) Page 8 of 45

• 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.