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Progesterone for TBI going into Phase III Clinical Trials

Progesterone is a naturally occurring hormone found in both genders. The brain is loaded with progesterone receptors. Dr. David Wright, associate professor of emergency medicine at Emory University School of Medicine, is an expert on using progesterone in the emergency room to treat new cases of TBI. In an earlier 3 year trial on 100 patients he demonstrated that emergency treatment with progesterone reduced mortality by 50% in cases of severe TBI while improving functional outcome and reducing disability in people with moderate TBI.

Now the National Institute of Health has funded a grant to Emory University to conduct phase III clinical trials of progesterone on patients with TBI at 17 medical centers across the country. The study will enroll approximately 1,140 patients over a 3-6 year period beginning in March 2010. Dr. Wright will lead the study and Atlanta’s Grady Memorial Hospital will serve as the lead medical center with faculty from Emory School of Medicine and Morehouse School of Medicine. Dr. Wright said that no new treatment for severe TBI had been approved in the past 30 years and he is very excited about the promise of progesterone as a new treatment pending the outcome of the new study.