Clinical Trial

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

Study acronym: NICCOLO
Not Yet Recruiting Phase 3
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Summary
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
Trial Details
NCT Number NCT07270432
Lead Sponsor Ache Laboratorios Farmaceuticos S.A.
Conditions Prostatic Hyperplasia, Benign
Enrollment 218 participants
Start Date 2026-01
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-12-08