Study to Evaluate the Safety and Effectiveness of Tryptophan Compared to Tamsulosin in Men with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms

What this Trial Is About

Benign prostatic hyperplasia BPH is a common condition causing lower urinary tract symptoms LUTS in men, which sometimes require surgery when medication does not work. Researchers are studying whether 5-hidroxitriptophan Oxitriptan may help improve symptoms of BPH with possibly fewer sexual side effects than current treatments like tamsulosin. This phase 2 clinical trial aims to evaluate the safety and effectiveness of these treatments in men with BPH. Participants will be randomly assigned to take either tamsulosin 0.4 mg once daily or 5-hidroxitriptophan 100 mg three times daily for six months. This study is conducted at a single center and compares these two oral medications to see how they affect BPH symptoms over this period. During the study, men will be assessed at the start, 1 month, 3 months, and at the end of treatment 6 months using the International Prostate Symptom Score IPSS and other measures like urine flow rate and prostate volume. Sexual function will also be evaluated. Researchers will monitor symptom changes and safety throughout the study, which lasts six months in total.

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