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

NCT07270432 | Not Yet Recruiting Phase 3

• 1 other identifier: ACH-DTS-03(03/22)
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostatic Hyperplasia, Benign

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS)

  Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline

  180 days

Study Arms (2)

Product DNN.65.21.005

EXPERIMENTAL

Drug: Product DNN.65.21.005

Combodart®

ACTIVE COMPARATOR

Drug: Combodart®

Interventions

Product DNN.65.21.005 DRUG

One capsule every 24 hours

Product DNN.65.21.005

Combodart® DRUG

One capsule every 24 hours

Combodart®

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11