A hunt through ClinicalTrials.gov: Who is recruiting puberty-blocked kids for research studies?

When gender critics and gender advocates spar, the more thoughtful opponents at some point usually attack and parry with links to published research. There is sparse conclusive evidence regarding transsexual or transgender adults, but at least you can link to what little there is when making your points.

When it comes to systematic studies of the growing number of children and adolescents undergoing medical “transition” via hormones and surgeries? Not so much. In fact, pretty much nothing. Zilch. Nada.

As I discussed in this post, pediatric gender specialists—endocrinologists, pediatricians, psychiatrists— openly acknowledge that there is essentially no research about the effects and outcomes of childhood medical transition.

So what generally happens when more data is needed about an accelerating and urgent medical problem, one for which experimental treatments are being prescribed? Teams of doctors and/or academic researchers write grants to fund rigorous studies. In the US, important medical research is often funded through the National Institutes of Health or other government-funded agencies. Given the increase in gender dysphoric kids popping up for treatment*, it seems likely the NIH would be quite amenable to funding well-designed studies. Particularly since the medical treatments for childhood gender dysphoria are so extreme that they can result in the permanent sterilization of minors.

There are plenty of potential research subjects being seen in gender clinics right now. While the practice is relatively new, hormone treatment for gender dysphoric kids has been ongoing in the US since 2007 (first cases at Boston’s Children’s hospital) and for over 20 years in the Netherlands. There has been ample time for researchers to apply for and receive funding.

What could be studied in these children who are having natural puberty arrested? I can think of a few interesting lines of research:

  • The physiological and psychological effects of GnRH agonists (“puberty blockers”) on gender dysphoric children and adolescents
  • The physiological and psychological effects on adolescents who have gone directly from GnRH agonists to cross-sex hormones
  • Brain activity and neurological effects on adolescents who have delayed puberty; such studies could include noninvasive MRI and fMRI brain scans, coupled with behavioral observations
  • Attitudes and opinions of gender dysphoric children and adolescents vis-à-vis permanent loss of fertility and how these attitudes and opinions change (or don’t change) over time
  • Executive function development in prepubescent children who are under treatment vs. a control group of children who are not treated
  • Long term outcome studies comparing gender dysphoric children who undergo hormone and surgical treatments vs. those who do not

There are many other avenues research could take. And these studies, to be meaningful, ought to be longitudinal (over the longest time span possible), and start as soon as possible after the child begins treatment.

So given the desperate need for research being called for by all the experts in the field, surely some studies have been funded and are actively recruiting subjects?

The place to find current research studies is ClinicalTrials.gov. (The database also lists recently closed studies that are no longer recruiting). ClinicalTrials.gov indexes all studies in the world—not just the US—which are seeking subjects.

Here’s a sample of what I found—more to the point, what I didn’t find. I tried many permutations of keyword searches and came up essentially empty. I encourage readers to do their own searches and tell us your results in the comments section.

  • Puberty blocker: 0
  • GnRH agonist: Hundreds—but all for either cancer patients or for precocious puberty
  • GnRH agonist gender dysphoria: 0
  • GnRH agonist child gender: 0
  • GnRH agonist fertility: 99, all about adult cancer patients
  • MRI gender dysphoria: 0
  • Child (or adolescent) transgender: 4, all about HIV prevention
  • Gender dysphoria: 3, all about HIV risk
  • Adolescent transgender: 2, both about HIV prevention
  • Leuprolide [generic name for Lupron, a puberty  blocker]: Hundreds—but all for either cancer patients or for precocious puberty
  • Leuprolide transgender: 0

When it comes to medicine, if there are no current studies recruiting new subjects, it typically indicates that the research questions have been more or less settled. A clinical problem or hypothesis has been thoroughly explored, studies have been conducted, the results have been replicated, and evidence-based clinical practice follows from there.

But the use of off-label GnRH agonists followed by cross-sex hormones on prepubescent children is new. We don’t have the data.  And unless someone collects that data in a systematic way, we will never know the outcome of this grand experiment on young people.

What we have now are anecdotes, personal testimonies, and shrill voices demanding medical transition for children NOW.  The usual reason given is suicide prevention. But if innate gender is real, this means there have been “transgender” children and adolescents since the dawn of human history. Yet there is no prior record of nor claim of suicidal children claiming to be “in the wrong body” before the modern age, when pharmaceutical and surgical solutions have become de rigeur.

Surely we can all agree that any treatment meant to prevent suicide; any treatment resulting in possible sterilization of minors deserves serious and wide-ranging study. Someone needs to get moving.

But the evidence suggests—no one is.

As one detransitioned woman has said, “We aren’t even lab rats.”

*A cursory Internet search reveals many stories about the steady increase in kids referred to gender clinics throughout the Western world

7 thoughts on “A hunt through ClinicalTrials.gov: Who is recruiting puberty-blocked kids for research studies?

  1. I have also done extensive searches through databases for strong and concrete evidence that the hormone regimes and surgeries are safe, that trans-identified people are happier, that they do not have co-morbid mental health problems, or even the aetiology of the transsexual phenomenon. there are no reliable, concrete studies that have been replicated or even done on human subjects. it leaves me with a cold chill down my spine, realising that my sibling is so ill because nobody is bothering to really check the side-effects…however, i was not reassured by the words on the WPATH website that writes about the causes: This is from the organisation WPATH (none of them are science researchers) that is informing people and the media about transsexuality : “Aetiology
    There is likely to be a balance of a number of genetic, hormonal and environmental factors involved in gender dysphoria, but THE CAUSE IS ESSENTIALLY UNKNOWN. ” My caps….OMG…..There is no science that currently exists that actually states that this is physical in any way….they say it themselves. What other “condition” do we treat with dangerous medications and surgeries that have no known physical cause, or evidence of the success? My new philosophy that I wrote today: If you have to change who you are, then you are not being real to your real self…..this new trans narrative of being the genuine authentic self….if you have to change yourself, then you are not being authentic to who you are….great to hear the opposition rising so civilly and intelligently. thanks for the opportunity to communicate my thoughts….

    Liked by 2 people

  2. Dammit. Now I’m just pissed. Great work 4thwave. Too bad some of the ‘kingpins’ discussed in your prior blog are not showing up in this listing of research projects.

    I spent the weekend reading “Galileo’s Middle Finger” by Alice Dreger, medical ethicist who’s been much vilified by transactivists (mainly Andrea James but also others) for her writing in support of her Northwestern University colleague Michael Bailey regarding the theory of autogynephilia. The book discusses the confluence of research, academia, and sociopolitical agendas using several stories in which Dreger’s been involved — mostly not involving trans, other than Bailey’s section. (She has also written multiple times on transing of minors, but this is only glancingly mentioned in the book.) Her work reveals how quality research can be vilified and researchers discredited for reasons that have nothing to do with the quality of the research — and, conversely, how work that is suspect from a purely scientific standpoint can be embraced for non-scientific reasons.

    To me the most horrifying section of the book is her dirt-digging regarding pediatric endocrinologist Dr. Maria New, formerly of Weill Cornell med school and now at Mount Sinai, both in NYC. New pioneered the off-label use of a drug called dexamethasone (or ‘dex’) to prevent development of intersex conditions in fetal females, at risk due to congenital adrenal hyperplasia. As with the pediatric transition kingpins, New advised the adult parents of these babies that dex is ‘safe and effective,’ even though she never really conducted research to affirm this. Over years, kids treated this way started to exhibit behavioral and cognitive deficits. Dreger’s research uncovered the shoddy oversight involved in this situation, though New was never sanctioned at all and in fact continues to administer dex, even though the consents these parents have signed do not appear to be honest regarding the risks. (This TIME magazine story from 2010 gives background and a good summary of the ethical issues: http://content.time.com/time/health/article/0,8599,1996453,00.html )

    Parents who’ve contacted Dreger emphasize that New and her acolytes never revealed the non-verified nature of the claims they were making for the benefits of dex — a point also made in the story. Dreger, who previously did a lot of advocacy work on behalf of intersex people campaigning against routine surgeries to ‘correct’ intersex, makes the point that what’s really being treated here is not any emergency health condition but rather PARENTAL ANXIETY, FEAR and DISCOMFORT.

    And I think this is very true of the current pediatric transing situation, which mirrors the dex controversy in so many ways. Not all families presenting kids have suicidal kids, but … all of them think there’s something wrong that needs urgent treatment, even with UNPROVEN protocols. I think in many cases these families are in social settings where it’s a lot more comfortable to have a kid that ‘looks normal’ than a kid that ‘looks weird,’ you know. Ergo, the pressure to trans your kid could be a lot greater in a conservative milieu than in a place where differences are accepted a little more readily. (On the other hand — if you’re in a ‘superprogressive’ environment there’s also going to be pressure to trans, you know? because .. .’progressive.’ Aieee.)

    Dreger’s very even handed, has always stressed that some percentage of nonconforming people are going to do better after transition, but like you, 4thwave, she’s blowing the whistle about the inevitable false positives. She emphasizes that a mix of good intentions, desire to relieve suffering, and potential career-building pioneering work and funding — these are things that can bring about such ethically suspect situations.

    I fully expect that some parents would choose to trans their kids, regardless of all this knowledge. But your work is so important in at least ensuring that their consent is more INFORMED, and that it’s not taking place in a vacuum that ignores history.

    Me? Now knowing what I know … I would not take my kid to a ‘pediatric gender clinic’ EVER. If she grows to want to trans later, that’s her choice, but … this current paradigm is not a good thing.

    Liked by 3 people

    • Thank you for this! Great information. And I wrote this post after getting angry myself while searching through ClinicalTrials.gov. How can all these gender specialists just keep bemoaning the lack of evidence–while not spearheading major studies?

      Liked by 2 people

  3. *A cursory Internet search reveals many stories about the steady increase in kids referred to gender clinics throughout the Western world

    But jenudh identity is totally internal!!! Not influenced by culture at all!!! They all just happen to be awakening to their true selves ™ in this era.

    Liked by 1 person

  4. The book’s well worth a read. Dreger had do to multiple FOIA filings to get info, and … the info is chilling. New wasn’t just trying to prevent intersex conditions but also apparently to make females affected by CAH be less masculine and more interested in men and in motherhood. Gay activist and author Dan Savage (someone who’s been associated w/Dreger off and on) blogged about this apparent lesbian-prevention program here… http://slog.thestranger.com/slog/archives/2010/06/29/doctor-treating-pregnant-women-with-experimental-drug-to-prevent-lesbianism

    It all sounds so danged familiar, yes?

    Liked by 1 person

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s