10.Mar.2016

OCT reaches first-patient-in milestone in phase II clinical trial

This is a phase II, double-blind, placebo-controlled, randomized clinical study in patients with asthenospermia.

This study aims to evaluate therapeutic efficacy, safety and tolerability of the study medicine administered to patients with asthenospermia in various dosing regimens with optimal therapeutic dose and schedule in order to allow further investigations.

More than 70 male subjects between 20 and 55 years old are expected to be randomized into the study. Two investigational sites are engaged in enrollment of patients in Russia. The first patient was enrolled on December 8, 2015. At the moment, there are more than 20 patients enrolled for this study. 

Male infertility may be caused by different risk factors such as stress, uncontrolled use of different drugs (such as antibiotics) without prescription, increased radiation exposure, male reproductive system diseases (e.g. prostatitis), injuries, nutritional deficiencies, and many other reasons. To date, there are no treatments that have proven to be effective in the management of male infertility. This study is expected to demonstrate the safety and efficacy of the newly developed drug.

As part of this study, OCT is responsible for all arrangement activities, regulatory support, full project management and monitoring, working with study sites, local ethic committees, and data management. At the moment, OCT successfully completed more than 200 clinical trials. Our team of 150 professionals is dedicated to conduct high quality research of any complexity.