Enrollment target reached: 1030 patients for a phase III erectile disfunction study in 4 countries

OCT team has successfully completed recruitment of 1030 subjects for a phase III study of a drug for male erectile dysfunction. The study is running in Russia, Bulgaria, Ukraine and Latvia.

This is a dose ranging, multicenter, randomized, double-blind, placebo-controlled, home use, parallel group clinical trial with an open-label extension.

The study participants are male patients, aged from 18 to 70, who will undergo a 12-week treatment with three variations of dosage. The effect of a long-term therapy (up to 12 months) is to be evaluated as well. 

In this project OCT is responsible for all major activities including regulatory support, sites selection, logistics, project management and monitoring. Back to the list