drugset / Trial / NCT05023824

Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

NCT05023824 ↗

Phase 3 Unknown 300 enrolled Gangnam Severance Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.

Timeline

Start
2020-12-08
Primary completion
2023-12-07
Completion
2023-12-07

Outcome

Met primary endpoint

paper Results showed that the IPSS scores after 3 months of monotherapy were within the criteria for equivalence to those after 9 months of combination therapy. PMID 18542722 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dutasteride Small molecule — —
Comparator Finasteride Small molecule — —
Subject Tamsulosin Other / unclassified — —