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

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

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.

Study Overview

• Status: Recruiting
• Conditions: BPH; LUTS(Lower Urinary Tract Symptoms)
• Intervention / Treatment: Drug: Tamsulosin; Drug: 5-hidroxitriptophan

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rosana Magalhaes; Phone Number: +351 253 027 249; Email: cro@ccabraga.org
• Study Contact Backup: Name: Mónica Gonçalves; Phone Number: +351 253 027 249; Email: 2ca@ccabraga.org

Study Locations

• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Clinical Academic Center - Braga, Association (2CA-Braga)
    • Contact: Emanuel Dias; Phone Number: +351 253 027 249; Email: emanueldias@med.uminho.pt
    • Contact: Joana Sousa; Phone Number: +351 253 027 249; Email: coordenacao@ccabraga.org
    • Contact: Emanuel Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; tamsulosin 0.4mg (once a day) for 6 months.	Drug: Tamsulosin; Oral medication, once a day for 6 months.; Other Names: Omnic
Experimental: Experimental arm; 5-hidroxitriptophan 100 mg (3 times a day) for 6 months.	Drug: 5-hidroxitriptophan; Oral medication, 3 times a day for 6 months.; Other Names: Cincofarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (IPSS)	Evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS)	Change from baseline to day 1, 1-month, 3- month and EOT (6-month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qmax	Urine maximum flow rate	Change from baseline to EOT (6-month)
IIEF-5	Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5)	Change from baseline to EOT (6-month)
Prostate volume	Prostate volume (in cc), assessed by trans-rectal ultra-sound	Change from baseline to EOT (6-month)
question 8 of the IPSS	quality of life due to urinary symptoms (question 8 of the IPSS).	Change from baseline to EOT (6-month)

Collaborators and Investigators

• Sponsor: Clinical Academic Center (2CA-Braga)
• Investigators: Principal Investigator: Emanuel Dias, Hospital de Braga

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: LUTS; BPH; Tamsulosin; 5-HTP; Oxitriptan
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agents; Urological Agents; Adrenergic Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: TryptoBPH; 2021-000946-16 (EudraCT Number); 2024-519076-75-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No