Actively Recruiting

Phase 2
Age: 50Years - 74Years
MALE
NCT05401032

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

Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-01-06

70

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 74Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients with BPH for which tamsulosin is the therapeutic option per standard of care
  • Age 50 to less than 75 years old
  • Prostate volume 30 cm3 or larger by transrectal ultrasound (TRUS)
  • Diagnosed with lower urinary tract symptoms (LUTS) defined by a stable International Prostate Symptom Score (IPSS) total score of 13 points or more
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Post-void bladder residual volume of 250 ml or more
  • Intravesical obstruction from any cause other than BPH
  • History of any procedure considered an intervention for BPH
  • 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 alpha-reductase inhibitors within 6 months
  • Use of phytotherapy within 2 weeks before entry
  • Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors
  • Acute or chronic kidney failure
  • Diagnosed or suspected intolerance to lactose
  • General anesthesia in the past 4 weeks
  • Known intellectual disability that may impair giving informed consent or suitability for the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Braga, Portugal, 4710-243

Actively Recruiting

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Research Team

M

Mónica Gonçalves

CONTACT

R

Rosana Magalhães

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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