Vivus initiates Ph III trial of ED drug
US drugmaker Vivus has initiated the first of several pivotal Phase III studies of avanafil, an investigational erectile dysfunction drug.
The REVIVE trial is a randomized, double-blind, placebo-controlled, efficacy and safety study of avanafil in men with a history of ED. Subjects will undergo a four-week run-in period followed by 12 weeks of treatment. Subjects will be randomized to placebo or one of three dose levels of drug. The primary endpoints of the study will be improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score.
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