Actively Recruiting
TryptoBPH - Study to Evaluate Safety and Effectiveness of Tryptophan Compared to Tamsulosin in Men With Benign Prostatic Hyperplasia
Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-01-06
70
Participants Needed
1
Research Sites
N/A
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, which sometimes require surgery when medication does not work. Researchers are studying whether 5-hidroxitriptophan (Oxitriptan) may help improve symptoms of BPH with possibly fewer sexual side effects than current treatments like tamsulosin. This phase 2 clinical trial aims to evaluate the safety and effectiveness of these treatments in men with BPH. Participants will be randomly assigned to take either tamsulosin 0.4 mg once daily or 5-hidroxitriptophan 100 mg three times daily for six months. This study is conducted at a single center and compares these two oral medications to see how they affect BPH symptoms over this period. During the study, men will be assessed at the start, 1 month, 3 months, and at the end of treatment (6 months) using the International Prostate Symptom Score (IPSS) and other measures like urine flow rate and prostate volume. Sexual function will also be evaluated. Researchers will monitor symptom changes and safety throughout the study, which lasts six months in total.
CONDITIONS
Brief 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...
- Written informed consent
- Male patients diagnosed with benign prostatic hyperplasia (BPH) for whom tamsulosin is the standard treatment
- Age 50 years or older and less than 75 years old
- Prostate volume of 30 cm3 or more measured by transrectal ultrasound
- Stable International Prostate Symptom Score (IPSS) of 13 points or higher indicating lower urinary tract symptoms
You will not qualify if you...
- Post-void bladder residual volume of 250 ml or more
- Urinary obstruction caused by conditions other than BPH
- History of any surgery or procedure to treat BPH
- Active or recurrent urinary tract infections
- Current or chronic prostatitis
- History of prostate or invasive bladder cancer
- Use of 5 alpha-reductase inhibitors within 6 months before the study
- Use of phytotherapy within 2 weeks before study entry
- Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors
- Acute or chronic kidney failure
- Diagnosed or suspected lactose intolerance
- General anesthesia within 4 weeks before study
- Intellectual disability interfering with informed consent or study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral medication daily for 6 months to evaluate safety and effectiveness of tryptophan compared to tamsulosin for benign prostatic hyperplasia.
Visits at baseline, 1 month, 3 months, and end of treatment (6 months)
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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