Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

Study Overview
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Brief Summary
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Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation. The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH. The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.

Official Title
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Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Drug: Permixon® 160 mg
* Drug: Tamsulosine Arrow LP
* Drug: Placebo matching Permixon® 160 mg
* Drug: Placebo matching Tamsulosine Arrow LP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patient Between 45 and 85 years old. Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2) Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2) I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits, 5 mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary) Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2) Serum total PSA at randomisation visit (visit 2) : 4 ng/mL 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit. Patient able to understand and sign the informed consent and understand and fill in self-questionnaires Exclusion Criteria: Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2). Urological history : Urethral stricture disease and/or bladder neck disease Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection Indication of BPH surgery Stone in bladder or urethra Acute or chronic (documented) prostatitis Prostate and cancer cancer treated or untreated Interstitial cystitis (documented by symptoms and/or biopsy) Active upper tract stone disease causing symptoms Patient with history of surgery of the prostate, bladder neck or pelvic region Any local and/or systemic inflammation disorders at selection and randomisation visit

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tested product<br> | Drug: Permixon® 160 mg<br>* Oral administration - 160 mg twice daily.<br>Drug: Placebo matching Tamsulosine Arrow LP<br>* Oral administration - daily.<br>|
| Active Comparator: Comparator<br> | Drug: Tamsulosine Arrow LP<br>* Oral administration - 0.4 mg daily.<br>Drug: Placebo matching Permixon® 160 mg<br>* Oral administration - twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Inflammation Biomarkers | Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 : Urine inflammation markers [mRNA (messenger RiboNucleic Acid) and proteins] on the first urine flow after digital rectal examination Serum inflammation markers (C-Reactive Protein and Sedimentation Rate)  | Day 1 (baseline), Day 30, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of urinary symptoms | Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire) | Day 1 (baseline), Day 30, Day 90 | 
| Change from baseline of quality of life | Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient | Day 1 (baseline), Day 30, Day 90 | 
| Change from baseline of sexual activity | Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire) | Day 1 (baseline), Day 30, Day 90 | 
| Change from baseline of maximum urinary flow rate | Uroflowmetry performed using an electronic flow meter. | Day 1 (baseline), Day 30, Day 90 | 
| Change from baseline of prostate volume | Prostate volume determined by transrectal ultrasound | Day 1 (baseline), Day 30, Day 90 | 
| Change from baseline of post-void residual urine volume (PVR) | Post-void residual urine volume determined by suprapubic ultrasound. | Day 1 (baseline), Day 30, Day 90 | 
| Number of adverse events | Number of adverse events | up to 90 days |