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.
yes, but I think you might not understand what this means.
Yes, which is why transitioning is possible, along with wonderful hormones that make up your “biology”
Actually that’s the gender roles that are causing oppression! They’re just based on certain physical characteristics, which we can change easily. and yet you still bitch about people changing them. You reduce gender to social construct as if that negates it and then get upset when people play with their socially constructed identity.
You clearly have a lot of trauma based on your uterus, which is honestly a great excuse to be hateful towards another oppressed group, keep on doing what you’re doing, no notes or changes necessary, you are very healthy and stable.
Seriously it’s just such dishonesty. you have a problem with gender roles and yet you reinforce them by disparaging those trying to break them. you feel like "I would have transitioned, if… " Well you DIDN’T, Helen, and you aren’t them and they aren’t you. Stop pretending your experience speaks for them and stop negating theirs based on yours.
it’s just absolutely arrogant, you must be such a self-centered obnoxious person. I bet you smell like cheap perfume and unwashed ass. A person who tries so hard to sit at the boys table but hates herself every second of trying should maybe spend some time developing EQ instead of lashing out against an already oppressed group. what the fuck is wrong with you?
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?