PERmixon® in LUTS Evaluation Study (PERLES)

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Permixon; Saw palmetto extract; Tamsulosin

Criteria

Inclusion Criteria:

• Male subject

• Between 45 and 85 years old

• Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream

• Subject naive to any prior treatment for LUTS due to BPH

• Prostate enlargement at digital rectal examination (DRE) suggestive of BPH

• I-PSS > 12 at enrolment visit and at inclusion visit

• QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit

Exclusion Criteria:

• Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)

• Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle

• Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus

• Known severe renal insufficiency or creatinine clearance < 30 ml/mn

• Known liver insufficiency or clinically significant abnormal liver function tests

• History of, or concomitant, cardiac arrhythmia or angina pectoris

• Orthostatic hypotension at enrolment or inclusion visit

• Known hypersensitivity to one of the constituents of the study drugs

• Is participating in another clinical trial