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

Phase 2

Recruiting

• Conditions: BPH; LUTS(Lower Urinary Tract Symptoms)
• Interventions: Drug: Tamsulosin; Drug: 5-hidroxitriptophan

• Registration Number: NCT05401032
• Lead Sponsor: Clinical Academic Center (2CA-Braga)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Study Start: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Tamsulosin	tamsulosin 0.4mg (once a day) for 6 months.
Experimental arm	5-hidroxitriptophan	5-hidroxitriptophan 100 mg (3 times a day) for 6 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Academic Center - Braga, Association (2CA-Braga); 🇵🇹 Braga, Portugal