Clinical trial NCT05401032: Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
Official title: TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: BPH
LUTS(Lower Urinary Tract Symptoms)
Keywords: BPH
LUTS
5-HTP
Oxitriptan
Tamsulosin
Lead sponsor: Clinical Academic Center (2CA-Braga)
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 70
Sex: MALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, parallel group, randomized clinical trial designed to evaluate the effect of treatment with 5-HTP, comparative to Tamsulosin, for a period of 6 months, on LUTS, changes in urine maximum flow rate (Qmax), prostate volume, erectile function and quality of life due to urinary symptoms in adult patients with BPH.
Primary purpose: TREATMENT

Brief summary: 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.


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:

* Patients with post-void bladder residual volume ≥250 ml;
* Patients with intravesical obstruction from any cause other than BPH;
* History of any procedure considered an intervention for BPH;
* 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;
* 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Change from baseline to day 1, 1-month, 3- month and EOT (6-month)
Secondary outcomes:
measure: Qmax
timeFrame: Change from baseline to EOT (6-month)
measure: IIEF-5
timeFrame: Change from baseline to EOT (6-month)
measure: Prostate volume
timeFrame: Change from baseline to EOT (6-month)
measure: question 8 of the IPSS
timeFrame: Change from baseline to EOT (6-month)
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Clinical Academic Center - Braga, Association (2CA-Braga)
Study officials:
affiliation: Hospital de Braga
name: Emanuel Dias
role: PRINCIPAL_INVESTIGATOR
References: