PERmixon® in LUTS Evaluation Study (PERLES)

Study Overview
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Brief Summary
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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.

Official Title
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PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Drug: Permixon® 160 mg
* Drug: Tamsulosine LP
* Drug: Placebo matching Permixon® 160 mg
* Drug: Placebo matching Tamsulosine LP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Permixon® 160 mg & Placebo<br> | Drug: Permixon® 160 mg<br>* Oral administration - 160 mg twice daily.<br>Drug: Placebo matching Permixon® 160 mg<br>* Oral administration - twice daily.<br>Drug: Placebo matching Tamsulosine LP<br>* Oral administration - daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo matching Permixon® 160 mg<br>* Oral administration - twice daily.<br>Drug: Placebo matching Tamsulosine LP<br>* Oral administration - daily.<br>|
| Other: Tamsulosine LP & Placebo<br>Active control arm | Drug: Tamsulosine LP<br>* Oral administration - 0.4 mg daily.<br>Drug: Placebo matching Permixon® 160 mg<br>* Oral administration - twice daily.<br>Drug: Placebo matching Tamsulosine LP<br>* Oral administration - daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (I-PSS score) change | I-PSS score change from baseline to D180 | Day 180 |