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.

  • LadyAutumnEnglish
    14·
    1 year ago

    Something as life-changing as puberty should be too. What if you grow up to regret having gone through forced puberty like I did? The damage is unbelievable and, in some instances, can never be reversed.

    If hormones for trans teens are “quite scary” then necessarily puberty for all teens is “quite scary”. Should we thusly force everyone to take puberty blockers until they’re 18? Or do you trust cis children to know their gender but not trans children?

    You clearly don’t even understand what trans people are. It’s really not something you can simply convince yourself of, and by the age of 13 under direct supervision of psychologists and doctors a trans child should be able to avoid going through what I and many other trans people go through. I knew I wanted to be a girl when I was 5. I never had access to gender affirming care until I was 18. It has traumatized me for life and done untold amounts of damage to my body and my mind. I am not alone. Knowing that you’re a girl is different than “playing pretend” or “having a phase”. It’s not even remotely the same. It’s something fundamental about who you are, something that affects every single aspect of your life from the day you’re born until you die. Trans children should be allowed to go through the hormonal development they choose. No one should be forced to undergo hormone changes that mortally horrify them. No one should be forced to pretend they’re a gender they aren’t.

    This shit takes lives. Trans kids are one of the highest risk categories for young suicide. This isn’t a joke, this isn’t a game, and it’s about time that you and other ill-informed people sat back and let actual professionals take care of their patients.