Puberty Blockers for Gender Dysphoria

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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Children and adolescents experiencing gender dysphoria feel increased distress with the onset of puberty. Gender clinics treat these young adolescents by "blocking" puberty using gonadotropin-releasing hormone (GnRH) agonist medications. This has the possibility of impacting bone development as sex steroids are important to bone mass development. In this multi-site study, the investigators will examine bone marrow composition (by MRI) in 40 transgender youth and bone density and body composition before/after pubertal blockade compared to healthy participants.

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+