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DNN.65.21.005 in Benign Prostatic Hyperplasia
NCT07270432Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2026
- Primary completion
- Apr 2027
- Modality
- Small Molecules
- Conditions
- benign prostatic hyperplasia (BPH)
01
Overview
Phase 3, randomised, double-blind trial of dutasteride + tamsulosin hydrochloride in benign prostatic hyperplasia (BPH) (2 arms), sponsored by Aché Laboratórios Farmacêuticos. Primary endpoint: International Prostate Symptom Score at 180 days. Planned start Jan 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Product DNN.65.21.005
Experimental drug DNN.65.21.005
Combodart®
Active comparator (dutasteride + tamsulosin)
03
Who it enrols
Men aged 50+ with LUTS associated with BPH, excluding those with prostate cancer, significant urinary retention, or recent use of alpha-blockers or 5-alpha reductase inhibitors.
04
Endpoints
Primary
International Prostate Symptom Score
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