233

A nonprofit group is pushing to get estrogen FDA approved for gender-affirming care (www.statnews.com)

submitted 2 years ago by MicroWave@lemmy.world to c/news@lemmy.world

13 comments fedilink hide all child comments

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.

you are viewing a single comment's thread
view the rest of the comments

[-] littlewonder@lemmy.world 9 points 2 years ago

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.

this post was submitted on 28 Nov 2023

233 points (100.0% liked)

News

36063 readers

2788 users here now

Welcome to the News community!

Rules:

1. Be civil

Attack the argument, not the person. No racism/sexism/bigotry. Good faith argumentation only. This includes accusing another user of being a bot or paid actor. Trolling is uncivil and is grounds for removal and/or a community ban. Do not respond to rule-breaking content; report it and move on.

2. All posts should contain a source (url) that is as reliable and unbiased as possible and must only contain one link.

Obvious biased sources will be removed at the mods’ discretion. Supporting links can be added in comments or posted separately but not to the post body. Sources may be checked for reliability using Wikipedia, MBFC, AdFontes, GroundNews, etc.

3. No bots, spam or self-promotion.

Only approved bots, which follow the guidelines for bots set by the instance, are allowed.

4. Post titles should be the same as the article used as source. Clickbait titles may be removed.

Posts which titles don’t match the source may be removed. If the site changed their headline, we may ask you to update the post title. Clickbait titles use hyperbolic language and do not accurately describe the article content. When necessary, post titles may be edited, clearly marked with [brackets], but may never be used to editorialize or comment on the content.

5. Only recent news is allowed.

Posts must be news from the most recent 30 days.

6. All posts must be news articles.

No opinion pieces, Listicles, editorials, videos, blogs, press releases, or celebrity gossip will be allowed. All posts will be judged on a case-by-case basis. Mods may use discretion to pre-approve videos or press releases from highly credible sources that provide unique, newsworthy content not available or possible in another format.

7. No duplicate posts.

If an article has already been posted, it will be removed. Different articles reporting on the same subject are permitted. If the post that matches your post is very old, we refer you to rule 5.

8. Misinformation is prohibited.

Misinformation / propaganda is strictly prohibited. Any comment or post containing or linking to misinformation will be removed. If you feel that your post has been removed in error, credible sources must be provided.

9. No link shorteners or news aggregators.

All posts must link to original article sources. You may include archival links in the post description. News aggregators such as Yahoo, Google, Hacker News, etc. should be avoided in favor of the original source link. Newswire services such as AP, Reuters, or AFP, are frequently republished and may be shared from other credible sources.

10. Don't copy entire article in your post body

For copyright reasons, you are not allowed to copy an entire article into your post body. This is an instance wide rule, that is strictly enforced in this community.

founded 2 years ago

MODERATORS

JonsJava@lemmy.world

gedaliyah@lemmy.world

little_cow@lemmy.world