OCT is to Conduct a Study of a Drug for Erectile Dysfunction within 4 CountriesOCT team obtained approval from Bulgarian regulatory authorities to conduct a Phase III study of a drug for male erectile dysfunction. Russia, Ukraine and Latvia will also be involved in this study. All in all, 700 patients will be enrolled in four countries.
This is a dose ranging, multi-centre, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial with an open-label extension.
The study participants include over 700 male patients, ages 18 to 70, who will undergo treatment over a twelve-week period 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