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) (PERMIN)
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.
|Benign Prostatic Hyperplasia (BPH)||Drug: Permixon® 160 mg Drug: Tamsulosine Arrow LP Drug: Placebo matching Permixon® 160 mg Drug: Placebo matching Tamsulosine Arrow LP||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||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|
- Change from baseline of Inflammation Biomarkers [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]
"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) "
- Change from baseline of urinary symptoms [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)
- Change from baseline of quality of life [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient
- Change from baseline of sexual activity [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)
- Change from baseline of maximum urinary flow rate [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Uroflowmetry performed using an electronic flow meter.
- Change from baseline of prostate volume [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Prostate volume determined by transrectal ultrasound
- Change from baseline of post-void residual urine volume (PVR) [ Time Frame: Day 1 (baseline), Day 30, Day 90 ]Post-void residual urine volume determined by suprapubic ultrasound.
- Number of adverse events [ Time Frame: up to 90 days ]Number of adverse events
|Study Start Date:||June 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Experimental: Tested product||
Drug: Permixon® 160 mg
Oral administration - 160 mg twice daily.Drug: Placebo matching Tamsulosine Arrow LP
Oral administration - daily.
|Active Comparator: Comparator||
Drug: Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.Drug: Placebo matching Permixon® 160 mg
Oral administration - twice daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604811
|La Tronche, France|
|Le Fousseret, France|
|Saint Orens de Gameville, France|