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

ConditionProstatic Hyperplasia, Benign

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexMale

Age50+

SponsorAche Laboratorios Farmaceuticos S.A.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

218 Participants

are divided into 2 treatment groups

Group A: Product DNN.65.21.005Experimental treatment 1 intervention

Group B: Combodart®Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in International Prostate Symptom Score (IPSS)

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

Time frame

180 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ache Laboratorios Farmaceuticos S.A.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: