Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia

Inclusion Criteria: * Male participants aged 50 years and older. * Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF). * Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes. Exclusion Criteria: * History or evidence of prostate cancer. * Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound. * Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder. * Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit. * Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment. * Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment. * Use of any prohibited medications within the timeframe specified in the study protocol. * Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.