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Phase 3 trial does not confirm the efficacy of progesterone for TBI

Data from the phase 3 PROTECT trial indicate progesterone provided no significant improvement of outcomes over placebo in patients with acute traumatic brain injuries.

“Despite extensive preclinical data from two promising single-center trials, progesterone was not associated with any benefit over placebo,” David W. Wright, MD, from the Department of Emergency Medicine at Emory University School of Medicine and Grady Memorial Hospital, and colleagues wrote. 

David W. Wright

In a double-blind, multicenter clinical trial, the researchers studied a total of 882 patients with severe, moderate-to-severe or moderate acute traumatic brain injury (according to the Glasgow Coma Scale) between April 5, 2010 and Oct. 30, 2013. Patients were randomly assigned to IV progesterone or placebo. Treatment was initiated within 4 hours of the injury and was administered for a total of 96 hours.

The trial was stopped after the second interim analysis due to futility. The researchers found no significant difference of favorable outcomes between the progesterone group (51%) and the placebo group (55%) (relative benefit=0.95%; 95% CI; 0.85-1.06).

Disclosure: The researchers report receiving a grant for the study from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. See the study for a full list of the researchers’ relevant financial disclosures.