Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia
NCT07270432 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2025-12-08
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
Interventions
- DRUG
-
Product DNN.65.21.005
One capsule every 24 hours
- DRUG
-
Combodart®
One capsule every 24 hours
Sponsors & Collaborators
-
Ache Laboratorios Farmaceuticos S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
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