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

NCT05401032 | Recruiting Phase 2 DMC

• 3 other identifiers: TryptoBPH2024-519076-75-002021-000946-16
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

BPH; LUTS; 5-HTP; Oxitriptan; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Qmax

  Change from baseline to EOT (6-month)

• IIEF-5

  Change from baseline to EOT (6-month)

• Prostate volume

  Change from baseline to EOT (6-month)

• question 8 of the IPSS

  Change from baseline to EOT (6-month)

Study Arms (2)

Control arm

ACTIVE COMPARATOR

tamsulosin 0.4mg (once a day) for 6 months.

Drug: Tamsulosin

Experimental arm

EXPERIMENTAL

5-hidroxitriptophan 100 mg (3 times a day) for 6 months.

Drug: 5-hidroxitriptophan

Interventions

Tamsulosin DRUG

Oral medication, once a day for 6 months.

Also known as: Omnic

Control arm

5-hidroxitriptophan DRUG

Oral medication, 3 times a day for 6 months.

Also known as: Cincofarm

Experimental arm

Eligibility Criteria

• Age: 50 Years - 74 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Academic Center (2CA-Braga): lead

Study Sites (1)

Clinical Academic Center - Braga, Association (2CA-Braga)

Braga, 4710-243, Portugal

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Emanuel Dias

  Hospital de Braga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mónica Gonçalves

CONTACT

+351 253 027 249; 2ca@ccabraga.org

Rosana Magalhães

CONTACT

+351 253 027 249; cro@ccabraga.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Complete (double) blinding is not possible to achieve, nonetheless, in order to lessen assessment bias, efficacy and safety assessment procedures will be performed by the assigned blinded research staff. In order to assure blinding across the study, randomization data will be kept confidential and will not be accessible to anyone, except to unblinded research staff, pharmacy staff. Both groups will be monitored for the same study duration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, parallel group, randomized clinical trial designed to evaluate the effect of treatment with 5-HTP, comparative to Tamsulosin, for a period of 6 months, on LUTS, changes in urine maximum flow rate (Qmax), prostate volume, erectile function and quality of life due to urinary symptoms in adult patients with BPH.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

PT (1)