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