New nonprofit pushes for FDA approval of gender hormone therapy through clinical trials

A nonprofit founded in early 2023 is working with the Food and Drug Administration (FDA) on a potential clinical trial to gain federal approval for transgender hormone treatment, according to a recent LinkedIn post.

The Research Institute for Gender Therapeutics (RIGT), a nonprofit organization dedicated to getting transgender hormone treatments approved by the FDA, submitted a clinical trial proposal to the agency in early 'this year and said received a response that “gives us a pretty clear path to federal approval for gender-affirming care,” she posted on LinkedIn. The possible judgment would test estradiol, a form of estrogen, to study its effectiveness as a treatment for gender dysphoria, and the FDA suggested including children as young as 13, according to the publication.

The FDA also suggested not including a control group in the potential trial, according to the publication. In pharmaceutical tests, a control group is a set of individuals receiving a placebo treatment that researchers can compare with a group given the actual treatment to understand the impact of the drug in question.

“Through its discussions with RIGT, the FDA has officially recognized the medical suitability of a formal development program for gender affirmation, marking a significant milestone for the gender diverse community,” the statement from press of RIGT.

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 offers drug sponsors several approaches to study the appropriate design to evaluate their proposed use of the drug both scientifically and ethically,” the statement continued.

Doctors in many states already give children transgender hormones, seconds in pharmaceutical technology. They to prescribe “off-label” medications, meaning the hormones are approved to treat conditions other than gender dysphoria.

Some doctors believe 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 Gender Affirming Health Program at the University of California, San Francisco, and Dr. Meredithe McNamara, Assistant Professor of Pediatrics at the Yale School of Medicine, he said Politician that FDA approval of estradiol as a treatment for gender dysphoria could be used as a legal argument against red state bans.

RIGT also plans to seek FDA approval for transgender testosterone treatments and puberty blockers in the future, STAT News reported.

two outside of three of RIGT's founders work as pharmaceutical executives, according to the group's website. The pharmaceutical industry has it funded research that promotes child gender transitions through study funding.

Transgender Hormone Therapy Market Size to be USD 1.6 Billion in 2022, seconds at Grand View Research.

RIGT did not immediately respond to DCNF's requests for comment.

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