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)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DRUG	Permixon® 160 mg	Oral administration - 160 mg twice daily.
DRUG	Tamsulosine Arrow LP	Oral administration - 0.4 mg daily.
DRUG	Placebo matching Permixon® 160 mg	Oral administration - twice daily.
DRUG	Placebo matching Tamsulosine Arrow LP	Oral administration - daily.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-05-24
• Last updated: 2014-01-15

Locations

32 sites across 4 countries: France, Italy, Portugal, Spain