The Phase III randomized, double-blind, placebo-controlled, parallel-design clinical study, assessed the safety and efficacy of Cialis 2.5 or 5 mg for once daily use in 606 sexually active men.
Lilly submitted the study in the supplemental new drug application to the US Food and Drug Administration (FDA) last year seeking approval for Cialis as a treatment for ED and BPH.
The study is available online in The Journal of Sexual Medicine.