PERmixon® in LUTS Evaluation Study (PERLES)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02121613

Acronym

PERLES

Enrollment

833

Registered

2014-04-23

Start date

2014-04-30

Completion date

2016-06-30

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia (BPH)

Brief 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.

Interventions

DRUGPermixon® 160 mg

Oral administration - 160 mg twice daily.

DRUGTamsulosine LP

Oral administration - 0.4 mg daily.

DRUGPlacebo matching Permixon® 160 mg

Oral administration - twice daily.

DRUGPlacebo matching Tamsulosine LP

Oral administration - daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

45 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Czechia, France, Germany, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026