Our team is pleased to report the successful completion of the Phase 3 clinical trial to assess the safety and efficacy of the study medication for the treatment of endometriosis. Patient enrolment began in June 2021 and continued until August 2022 inclusive. The total enrolment in Ukraine amounted to 155 patients, compared to 89 planned at the beginning of the study.
GCT would like to take this opportunity to welcome the increasing number of trials approved and successfully launched by our colleagues in Ukraine since the beginning of 2023. We should also acknowledge the stable work of the regulatory authorities and vendors providing logistics of the study drug, biosamples and study related materials. The level of enrolment in the first weeks of this year far exceeded all expectations, which highlights the extremely high potential of Ukraine in clinical trials. What are the main reasons for the successful start of projects today? Of course, the first is the localization of the Russian war against Ukraine in the southeastern regions of the country, which allows to ensure the safety of patients and clinical trials data in other regions of Ukraine. Low competition for patients due to the critical decline in clinical trial applications in 2022, is another and no less significant factor.
What conclusions can be drawn for a prospective clinical trial sponsor? Firstly, Ukraine is open to new projects, and secondly, the sponsor will be more successful if it enters among the first in 2023 to take advantage of the of opportunities that has been created today.