Actively Recruiting
Study to Evaluate the Safety and Effects of Tryptophan Compared to Tamsulosin in Men with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms
Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-01-06
70
Participants Needed
1
Research Sites
105 weeks
Total Duration
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AI-Summary
What this Trial Is About
Benign prostatic hyperplasia (BPH) is a common condition causing lower urinary tract symptoms (LUTS) in men. Current treatments include alpha-1 adrenoreceptor antagonists and 5-alpha-reductase inhibitors, but many patients still require surgery due to resistant symptoms or complications. This study is a phase 2, single-center, randomized clinical trial evaluating the safety and effectiveness of tryptophan (5-hidroxitriptophan) compared to tamsulosin in men with BPH and LUTS. Participants will be randomly assigned to receive either tamsulosin 0.4 mg once daily or 5-hidroxitriptophan 100 mg three times daily, both taken orally for 6 months. The study is conducted at the Hospital de Braga's Urology department. The trial compares these treatments to investigate if 5-hidroxitriptophan can improve BPH symptoms without negatively affecting sexual function, which is a common side effect of current drugs. Throughout the 6-month treatment period, men will be evaluated using the International Prostate Symptom Score (IPSS) at baseline, day 1, 1 month, 3 months, and at the end of treatment. Researchers will monitor changes in symptoms and safety. The total participation time includes regular assessments to track symptom changes and any side effects associated with the treatments.
CONDITIONS
Official Title
Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
Who Can Participate
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Clinical Academic Center - Braga, Association (2CA-Braga)
Braga, Portugal, 4710-243
Actively Recruiting
Research Team
M
Mónica Gonçalves
R
Rosana Magalhães
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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