A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for 6 months in men with lower urinary tra...

Update Il y a 4 ans
Reference: EUCTR2010-020604-29

A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for 6 months in men with lower urinary tract symptoms(LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia(BPH)

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Extract

The primary objective of this study is to test the hypothesis that tadalafil 5 mg once daily co-administered with finasteride is superior to placebo once daily co-administered with finasteride for 12 weeks in improving the International Prostate Symptom Score (IPSS) in men with lower urinary tract symptoms (LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia (BPH).


Inclusion criteria

  • benign prostatic hyperplasia (BPH)