The FDA gave feedback on a nonprofit group's proposal for a phase III clinical trial focused on estradiol as a gender-affirming treatment for trans and gender-diverse patients.

Hormone replacement therapies have long been approved by the Food and Drug Administration for use by cisgender patients, such as women who take estrogen when going through menopause. Now, for the first time, a nonprofit group is pursuing research with the goal of FDA approval for the use of estrogen as a gender-affirming treatment for trans and gender-diverse patients.

The group, the Research Institute for Gender Therapeutics (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. RIGT submitted a development plan to the FDA for a phase III clinical trial focused on estradiol — the most common form of estrogen for hormone treatments — and received the agency’s written feedback on Nov. 17 in lieu of a live pre-investigational new drug meeting.

In response to the group’s plan, the FDA “positively surprised” the group by advising them not to do a placebo-controlled trial, said Brad Sippy, RIGT’s founding director and president. The FDA also suggested widening the study’s population to include adolescents as young as 13 years old. The feedback comes at a time when many states are banning hormone treatment and puberty blockers for youth.

“[The FDA’s] feedback validates that this [gender incongruence] is a treatable condition and validates the existence of that population, and really gives us a pretty clear path to a federal approval for gender-affirming care,” said Sippy.

  • RedSeriesEnglish
    22•1 year ago

    It includes 13 year olds because puberty blockers are included. No one is giving estrogen to children. If a child experiences gender dysphoria, their parents can have them work with a psychiatrist and their doctor to make sure they delay puberty so the child can keep growing and decide if they want to transition when they approach adulthood.

    Everything else you’ve said is bullshit. Your ignorance is not a free pass to make up facts and spread misinformation.

    Research shows that a lot of gender dysphoria is the result of puberty and medicalizing treatment of it creates a pipeline to further transition including surgeries, while if not treated, the dysphoria often desists after puberty.

    This right here, this is evil. If someone took you at your word here, they may choose to ignore or punish their child if they were experiencing gender dysphoria. I know you have no sources from any respected institution, and the medical community en masse rebuke this line of thinking.

    Edit: Both of the books the original commenter added to try and support their claims are books that posit TERF views that sex is biological and gender either doesn’t exist or is equally biological and cannot change. They dehumanize trans folks and their struggles. They are not medical studies or journals supporting their claims.