Menu
Not yet recruiting NCT07270432

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

Phase III Interventional Prostatic Hyperplasia, Benign

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Product DNN.65.21.005, Combodart®.
Who it may be relevant to
Registry conditions: Prostatic Hyperplasia, Benign. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Product DNN.65.21.005
    One capsule every 24 hours
  • Drug Combodart®
    One capsule every 24 hours

Primary outcome measures

  • Change in International Prostate Symptom Score (IPSS) [Time frame: 180 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07270432 · ACH-DTS-03(03/22)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗