Benign Prostate Hyperplasia MedDRA version: 20.0 Level: LLT Classification code 10065030 Term: BPH System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Cincofarm
Pharmaceutical Form: Capsule
Trade Name: Omnic
Product Name: tamsulosin
Pharmaceutical Form: Tablet
INN or Proposed INN: TAMSULOSIN
CAS Number: 106133-20-4
Concentration unit: m
Sponsors
Centro Clínico Académico - Braga, Associação (2CA-Braga)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Written informed consent must be obtained before any assessment is performed; • 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 (23); • Diagnosed with LUTS defined by a stable IPSS total score =13 points; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • patients with postvoid 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 a-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS) as assessed by the International Prostate Symptom Score (IPSS) on patients with known BPH.;Secondary Objective: To evaluate the effect of tryptophan supplementation on secondary endpoints, including changes in urine maximum flow rate (Qmax), prostate volume, assessed by trans-rectal ultra-sound, and erectile function, assessed by International Index of Erectile Function-5 (IIEF-5) and in quality of life due to urinary symptoms (question 8 of the IPSS).;Primary end point(s): The primary goal of the study is to demonstrate the superiority of tryptophan to tamsulosin for the improvement of LUTS associated with BPH. This will be measured by a change from baseline in the total score (questions 1–7) of the IPSS questionnaire. ;Timepoint(s) of evaluation of this end point: - clinical visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are three secondary efficacy endpoints: • Urine maximum flow rate (Qmax); • Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5); • Prostate volume (in cc), assessed by trans-rectal ultra-sound; • Quality of life due to urinary symptoms (question 8 of the IPSS). ;Timepoint(s) of evaluation of this end point: - clinical visit | — |
Countries
Portugal
Contacts
Public ContactMónica Gonçalves
Centro Clínico Académico - Braga, Associação (2CA-Braga)
Outcome results
None listed