drugset / Trial / NCT02503306

Efficacy and Tolerability Study of Avanafil in Russia

NCT02503306

Phase 3 Completed 189 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period: * The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina. * The change in score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. Secondary Objective: o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).

Timeline

Start
2015-07
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Avanafil Small molecule Oral

Indications