NCT02121613.

Study name	PERmixon® in LUTS Evaluation Study (PERLES)
Methods	Quadruple‐blinded randomized controlled trial
Participants	Inclusion criteria: Male subject Between 45 and 85 years old Bothersome LUTS due to BPH such as frequency (daytime or nighttime), urgency, sensation of incomplete voiding, delayed urination, or weak stream Naive to any prior treatment for LUTS due to BPH Prostate enlargement at DRE suggestive of BPH IPSS > 12 at enrollment visit and at inclusion visit QoL IPSS score ≥ 3 evaluated at enrollment visit and at inclusion visit Exclusion criteria: Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrollment 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 uncontrolled non‐insulin‐dependent diabetes mellitus Known severe renal insufficiency or creatinine clearance < 30 mL/min Known liver insufficiency or clinically significant abnormal liver function tests History of, or concomitant, cardiac arrhythmia or angina pectoris Orthostatic hypotension at enrollment or inclusion visit Known hypersensitivity to 1 of the constituents of the study drugs Is participating in another clinical trial
Interventions	Experimental: Permixon 160 mg and placebo Drug: Permixon 160 mg. Oral administration, 160 mg twice daily Drug: placebo matching Permixon 160 mg. Oral administration, twice daily Drug: placebo matching Tamsulosine LP. Oral administration, daily Placebo comparator: placebo Drug: placebo matching Permixon 160 mg. Oral administration, twice daily Drug: placebo matching Tamsulosine LP. Oral administration, daily Tamsulosine LP and placebo: active control arm Drug: Tamsulosine LP. Oral administration, 0.4 mg daily Drug: placebo matching Permixon 160 mg. Oral administration, twice daily
Outcomes	IPSS score change from baseline to 180 days
Starting date	Completed study (unpublished)
Contact information	Study Director: Karim Keddad, MD (Pierre Fabre Medicament) No other contact information available.
Notes

DRE: digital rectal examination; IPSS: International Prostate Symptom Score; LUTS: lower urinary tract symptoms; QoL: quality of life