Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
Recruiting
Phase 2
Interventional Study
BPH
LUTS(Lower Urinary Tract Symptoms)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 74
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Clinical Academic Center (2CA-Braga) · Other
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About This Trial
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, creati…
Trial Locations
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Eligibility Criteria
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.
Exclusion Criteria:…
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