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

November 26, 2025 updated by: Ache Laboratorios Farmaceuticos S.A.

Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

218

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Product DNN.65.21.005
Drug: Product DNN.65.21.005
One capsule every 24 hours
Active Comparator: Combodart®
Drug: Combodart®
One capsule every 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: 180 days
Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACH-DTS-03(03/22)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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