Puberty Blockers for Gender Dysphoria

Not currently recruiting at 1 trial location

Overseen By Amy M DiVasta, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Amy DiVasta, MD

Must be taking: GnRH agonists

Must not be taking: Glucocorticoids, Anticonvulsants

Disqualifiers: Cystic fibrosis, Celiac, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how puberty blockers, specifically GnRH agonists, impact bone health in transgender youth. These medications pause puberty, which can reduce distress for young people experiencing gender dysphoria, but they might affect bone development. Researchers will compare bone density and body composition in transgender participants before and after treatment and against cisgender peers. Good candidates for this trial are transgender children who are current patients at specific gender clinics and are just starting puberty blockers. As an unphased trial, this study allows participants to contribute to important research on the effects of puberty blockers on bone health.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not taken certain medications that affect bone health, like glucocorticoids or anticonvulsants, in the past 3 months. If you're on these medications, you might need to stop them before joining the trial.

What prior data suggests that GnRH agonists are safe for use in transgender youth?

Studies have shown that puberty blockers, known as GnRH agonists, have been safely used for many years to treat conditions like early puberty and endometriosis. These medications temporarily stop the body from producing sex hormones, pausing puberty. When discontinued, puberty resumes naturally.

Concerns exist about how puberty blockers might affect bone growth, as sex hormones contribute to bone strength. However, their long history of use in other conditions provides some reassurance about their safety. While more research is needed specifically for their use in gender dysphoria, current evidence suggests these treatments are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for gender dysphoria, which typically involves psychological support and social transition, the GnRH agonist used in this context directly pauses puberty. Researchers are excited about this treatment because it offers a reversible way to give transgender youth more time to explore their gender identity without the added stress of unwanted physical changes. This treatment works by blocking the hormones that trigger puberty, which is different from other support-focused approaches. This method provides a biological pause, allowing for a more personalized and thoughtful approach to transitioning during crucial developmental years.

What evidence suggests that GnRH Agonist might be an effective treatment for gender dysphoria?

Research shows that puberty blockers, known as GnRH agonists, can help transgender youth by delaying physical changes that may cause distress. In this trial, transgender participants will receive GnRH agonists to slow the development of features like facial hair and a deeper voice in those assigned male at birth, and to prevent breast growth and menstruation in those assigned female at birth. This delay gives young people more time to understand their gender identity before any permanent changes occur. However, while puberty blockers can delay changes, they don't make the body match one's gender identity. Research is ongoing about how these blockers might affect bone growth. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for transgender youth aged 9-14 who are experiencing gender dysphoria and have started puberty. Participants must be patients at specific clinics, within six weeks of starting a puberty-blocking treatment with GnRH agonists like Lupron or Vantas. They need to match controls by age, race/ethnicity, sex assigned at birth, and BMI. Those with metal implants, claustrophobia preventing MRI scans, recent use of certain medications affecting bones or chronic diseases impacting bone health cannot join.

Inclusion Criteria

I am between 9-14 years old if AMAB, or 9-13 if AFAB.

I am a patient at the Boston or Cincinnati Children's Hospital Transgender Clinic starting puberty blockers.

Be willing to give informed consent/assent (parent or legal guardian able to provide informed consent)

Exclusion Criteria

I have a chronic condition like cystic fibrosis that affects bone health.

I haven't taken drugs affecting bone health in the last 3 months.

You have metal in your body that would prevent you from having an MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pubertal blockade treatment using GnRH agonist medications

24 months

Visits at initiation, 12 months, and 24 months

Follow-up

Participants are monitored for changes in bone density, body composition, and mental health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GnRH Agonist

Trial Overview The study tests the effects of puberty blockers (GnRH Agonist) on bone marrow composition and bone density in transgender youth compared to healthy participants. It involves monitoring changes through MRIs before and after pubertal blockade to understand how these treatments affect skeletal development during this critical growth period.

How Is the Trial Designed?

Group I: Transgender Participant Experimental Treatment 1 Intervention

Transgender children at Tanner stage II or early Tanner stage III between the ages of 9 and 14. Must be a current patient at a gender patient and within 6 weeks of initiating pubertal blockade treatment

Group II: Cisgender Control Participant Active Control 1 Intervention

Cisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.

Who Is Running the Clinical Trial?

Amy DiVasta, MD

Lead Sponsor

Trials

1

Recruited

80+

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12294553/

Psychological and Physical Health Outcomes Associated with ... Puberty blockers do not change a youth's body in the desired direction and, therefore, are unlikely to contribute to significant improvements ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11235884/

Puberty suppression in adolescents with gender dysphoria Adolescents between 14 and 17 years old at first visit received GnRHa less frequently, but were more likely to begin GAHT and after a shorter time, as compared ...

3. opa.hhs.gov opa.hhs.gov/sites/default/files/2025-05/gender-dysphoria-report.pdf

Treatment for Pediatric Gender Dysphoria puberty blockers and hormones for children with gender dysphoria. The. Guardian. https://www.theguardian.com/australia-news/2025/jan/28 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206297

Psychosocial Functioning in Transgender Youth after 2 ... In this 2-year study involving transgender and nonbinary youth, GAH improved appearance congruence and psychosocial functioning.

5. mayoclinic.org mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/art-20459075

Puberty blockers for transgender and gender-diverse youth In people assigned male at birth, GnRH analogues slow the growth of facial and body hair, prevent voice deepening, and limit the growth of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9793415/

Pubertal Blockade and Subsequent Gender Affirming ... Sometimes colloquially called “puberty blockers,” they have been used safely for decades in children with precocious puberty, endometriosis, among other medical ...

7. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1691

Puberty blockers for gender dysphoric youth: A lack of sound ... Over 95% of youth treated with GnRH-analogs go on to receive cross-sex hormones. By contrast, 61-98% of those managed with psychological support ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9398484/

Transgender Youth Experiences with Implantable GnRH ... This descriptive study reports caregiver experiences with GnRH agonist implants among a cohort of youth followed in a pediatric hospital-based gender clinic.