Emory Director of Emergency Neurosciences David Wright will lead the third phase of a clinical trial using progesterone for the treatment of traumatic brain injuries (TBI) during a three-to-six year period beginning this month.

The third phase, Progesterone for Traumatic Brain Injury Experimental Clinical Treatment (ProTECT III), involves the intravenous administration of progesterone to 1,140 people as part of a randomized, double-blind and placebo-controlled experiment, Wright said. In other words, neither patients nor researchers will know who receives the progesterone and who receives the placebo at the time of injection.

Progesterone works by reducing brain swelling and inflammation, which occurs after TBI, Director of Emory’s Department of Emergency Medicine Brain Research Laboratory Donald Stein wrote in an e-mail to the Wheel.

As a developmental hormone, progesterone also helps to protect the fetus, which in turn assists brain development.

Stein said his research was inspired by his observation that females frequently recover better than males after trauma. Progesterone is a naturally occurring hormone involved in the female menstrual cycle and pregnancy.

“I think the results could change the face of how brain injury is treated around the world,” Stein wrote. “It would give emergency medicine doctors a first line of defense against a devastating illness.”

Wright said they noticed a 50-percent reduction of death, as well as improvement in the functional abilities of patients receiving the progesterone in pilot studies of the clinical trials.

Since TBI is life-threatening, the Federal Drug Administration allows for treatment with exception from informed consent, Wright said.

The use of progesterone, which is found in hormonal contraceptive pills, raised questions of whether the drug would effeminize men who received progesterone post-TBI. He explained that the drug breaks down quickly and is eliminated from the body within 12 hours.

“It’s not much of a concern, and it doesn’t feminize or cause breasts,” Wright said.

Because of the unprecedented nature of TBI, there is a registry on ProTECT III’s website, which protects those patients who do not want to participate in the study, Wright explained.

“The golden goose would be that it saved lives and improved functional outcomes in head injury patients,” Wright said. “We can do a few supportive things, but we don’t have a drug that really improves outcomes.”

— Contact Roshani Chokshi.