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TryptoBPH - Proof-of-concept study to evaluate the safety and efficacy of tryptophan in patients with BPH
EU CTIS ID: 2024-519076-75-00
What this study is testing
To evaluate the effect of tryptophan supplementation on lower urinary tract symptoms as assessed by the International Prostate Symptom Score (IPSS) on patients with known benign prostatic hyperplasia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent must be obtained before any assessment is performed
- Male patients with benign prostatic hyperplasia 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 likely can't join if
- Patients with postvoid bladder residual volume ≥250 ml
- 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
See the full eligibility criteria
- Written informed consent must be obtained before any assessment is performed
- Male patients with benign prostatic hyperplasia 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
- Patients with postvoid bladder residual volume ≥250 ml
- 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
- Patients with intravesical obstruction from any cause other than benign prostatic hyperplasia
- History of any procedure considered an intervention for benign prostatic hyperplasia
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.