NCT05401032

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Clinical Academic Center (2CA-Braga) · Academic / Other
• Sex: Male
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BPH
• LUTS(Lower Urinary Tract Symptoms)

Interventions

Type	Name	Description
DRUG	Tamsulosin	Oral medication, once a day for 6 months.
DRUG	5-hidroxitriptophan	Oral medication, 3 times a day for 6 months.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-06-02
• Last updated: 2025-01-06

Locations

1 site across 1 country: Portugal