IBSA Group and Granata Bio announces first patient screened in pivotal PROGRESS clinical trial of Progesterone-IBSA
Excerpt from the Press Release:
BOSTON, Oct. 20, 2022 /PRNewswire/ — IBSA Group and Granata Bio today announced the screening of the first patient in the pivotal phase III PROGRESS (PROGesterone fRozen Euploid blaStocyst tranSfer) clinical trial (Clinical Trials.gov Identifier: NCT04549116).
The PROGRESS study is a multicenter, randomized, controlled, double-blind, double-dummy study to evaluate the safety and efficacy of subcutaneous progesterone compared to vaginal progesterone for luteal phase supplementation in modified natural frozen euploid blastocyst transfer. The study is expected to enroll about 680 patients between the ages of 35-42 years old.
“The IBSA Group is excited for this key milestone in development of our subcutaneous progesterone in the United States. It has been approved in Europe since 2014 and continues to outperform our expectations in Europe and rest of world,” stated Giuseppe Mautone, Head of R&D Scientific Affairs of IBSA Group.
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