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

Ache Laboratorios Farmaceuticos

Status and phase

Not yet enrolling

Phase 3

Conditions

Prostatic Hyperplasia, Benign

Treatments

Drug: Product DNN.65.21.005

Drug: Combodart®

Study type

Interventional

Funder types

Industry

Identifiers

ACH-DTS-03(03/22)

Details and patient eligibility

About

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

Enrollment

218 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.