drugset / Trial / NCT01604811

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)

NCT01604811

Phase 4 Completed 206 enrolled Pierre Fabre Laboratories
RandomizedParallel-groupQuadruple-blindBasic science

Summary

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.

Timeline

Start
2012-06
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Permixon Unknown 160 mg Oral
Subject Tamsulosin Other / unclassified 0.4 mg Oral