Prostatic Hyperplasia, Benign
Conditions
Brief summary
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
Interventions
DRUGProduct DNN.65.21.005
One capsule every 24 hours
DRUGCombodart®
One capsule every 24 hours
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | 180 days | Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline |
Outcome results
None listed