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.
I hope it gets it but good luck Republicans will not allow this to pass. Hell that want to eradicate trans people.
Until we remove every fucking Republican from the government and the planet nothing like this will happen.
Emphasis on “removal from the planet”. Republicans aren’t human.
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No laws against killing sheep.
Fair lmao
It wasn’t already? Jesus Christ
Yeah a placebo trial would be evil. I think widening the trials is important too, but there’s probably a huge medical difference between a puberty-blocker trans puberty for an adolescent and an adult trans second puberty. While estradiol is a basic easy one, none of these meds are all that great for you - its just the medical need to transition is greater than most (not all) of the health risks.
This is actually quite scary that the recommendation is for children as young as 13 years old. 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. Growing up is difficult and confusing - how many of us decided we were Absolutely Something as a kid and then shrugged it off later? Something as life-changing as hormone therapy for a physically healthy child should be handled very, very carefully.
ETA: for a thoughtful discussion of these and other topics, I suggest reading Holly Lawford-Smith’s book Gender Critical Feminism (extremely well cited with primary sources) and Helen Joyce’s book Trans.
… quite scary … pipeline to transition … dysphoria often desists …
You worked really hard to throw every catch phrase possible into that.
It’s telling that the first one is you’re scared … which is a poor motivator because it means you make important decisions based on falsehoods and fear-mongering.
Stop it.
Feels before reals. If facts were on their side, they wouldn’t need the fear-mongering bullshit. This is straight out of the Christian right playbook.
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.
Good thing hormones are only prescribed in a minority of trans kids anyways, even though the vast majority of them do not desist as they get older. In fact, the majority of them continue on to transition as adults, and 99.5 or so percent of trans kids given just puberty blockers, much less hormones, grow to adulthood with no regrets.
Also, before you ask, I can provide sources, but that which is declared without evidence can be dismissed without evidence, especially when the dismissal is in line with literally every major medical organization, including the World Health Organization, due to the sheer amount of clear evidence that transition is a safe and effective treatment for gender dysphoria at any age.
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.
Research shows that the vast majority of trans kids are trans, and should get puberty blockers at the very least.
“Gender Critical” is just a euphemism for transphobic. You are nothing but a concern troll who is trying to hurt trans people.
Gender Critical Feminism is the conceptual framework that gender is a social construct, innate gender identity doesn’t exist, and biological sex is a class that causes oppression of women.
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I have trauma related to my uterus (nice armchair diagnosis there!) And yet my oppression is due to my societal gender role, not the organ I possess that you just accused me of having trauma from?
Do you see the illogic here?
