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)

PHASE4CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

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.

Trial Locations (32)

Unknown

Angers

Bordeaux

Cornebarrieu

Créteil

La Tronche

Le Fousseret

Limoges

Lyon

Marseille

Nice

Paris

Saint-Orens-de-Gameville

Segré

Seysses

Tiercé

Toulouse

Bari

Catanzaro

Florence

Genova

Milan

Perugia

Pisa

Trieste

Lisbon

Porto

A.Coruna

Barcelona

Bilbao

Madrid

Sabadell

Seville

All Listed Sponsors
lead

Pierre Fabre Medicament

INDUSTRY

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) | Biotech Hunter | Biotech Hunter