MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2014-01-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • France
  • Italy
  • Portugal
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604811 on ClinicalTrials.gov