CV NEWS FEED // The Food and Drug Administration (FDA) is reportedly interested in conducting a study of so-called “gender-affirming” drugs on minors, potentially with participants as young as 13.
According to POLITICO, the Research Institute for Gender Therapeutics (RIGT) “said the FDA had provided feedback on its proposal for a late-stage clinical trial studying the use of estradiol, a form of the hormone estrogen.” RIGT is a nonprofit that supports “transitioning” minors.
“The FDA response is significant because conducting a Phase III trial would pave the way for the agency to approve the hormone for its use in gender-affirming care,” POLITICO noted. “At the moment, health care providers who care for transgender patients must prescribe the hormone off-label.”
“RIGT initially proposed studying estradiol in adults and some adolescents of reproductive age with a randomized trial,” the POLITICO report continued. However, “[the FDA] suggested the company broaden its study to include children as young as 13.”
STAT News added that RIGT “was founded earlier this year with the mission of obtaining approval for gender-affirming hormones, which are currently prescribed to patients off-label without an explicit approval for trans health care.”
As of December 4, laws or policies prohibiting so-called “gender-affirming” procedures on minors have passed in 22 states, with legislation pending in four of them.