A nonprofit that was founded in early 2023 is working with the Food and Drug Administration (FDA) on a possible clinical trial to get transgender hormone treatment federally approved, according to a recent LinkedIn post.
The Research Institute for Gender Therapeutics (RIGT), a nonprofit dedicated to getting transgender hormone treatments approved by the FDA, submitted a proposed clinical trial to the agency earlier this year and said it received a response that “gives us a pretty clear path to a federal approval for gender-affirming care,” it posted on LinkedIn. The possible trial would test estradiol, a form of estrogen, to study its efficacy as a treatment for gender dysphoria, and the FDA suggested including children as young as 13, according to the post.
The FDA also suggested not including a control group in the potential trial, according to the post. In pharmaceutical testing, a control group is a set of individuals given a placebo treatment that researchers can compare to a group given the actual treatment to understand the impact of the drug in question. (RELATED: Big Pharma Funds Activist Group’s Effort To Push Trans Ideology On US Hospitals)
“Through its discussions with RIGT, FDA has officially recognized the medical appropriateness of a formal development program for gender-affirming care, marking a significant milestone for the gender-diverse community,” the RIGT press release reads.
(REUTERS/Brian Snyder)
The FDA told the Daily Caller News Foundation that it “cannot confirm or deny the existence of a pending product application or discuss the status of a pending application.”
“In general, our advice provides drug sponsors with various approaches to study design appropriate to assessing their proposed use of the drug both scientifically and ethically,” the statement continued.
Doctors in many states already give transgender hormones to children in a number of states, according to Pharmaceutical Technology. They prescribe drugs “off-label,” meaning that the hormones are approved to treat conditions other than gender dysphoria.
Some doctors believe that FDA approval for transgender hormone treatments could complicate Republican efforts to ban hormones from being given to children who identify as transgender, Politico reported.
Dr. Madeline Deutsch, medical director of the University of California, San Francisco’s Gender Affirming Health Program, and Dr. Meredithe McNamara, assistant professor of pediatrics at Yale School of Medicine, told Politico that FDA approval of estradiol as a treatment for gender dysphoria could be used as a legal argument against red state bans.
RIGT also has plans to seek FDA approval for transgender testosterone treatments and puberty blockers in the future, STAT News reported.
Two out of three of RIGT’s founders work as pharmaceutical executives, according to the group’s website. The pharmaceutical industry has funded research promoting child gender transitions by funding studies.
The market size of transgender hormone therapy was $1.6 billion in 2022, according to Grand View Research.
RIGT did not immediately respond to the DCNF’s requests for comment.
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