To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of 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.