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Hormone Therapy

Puberty Blockers for Gender Dysphoria

N/A
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tanner Stage II/III
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline compared to 24 months
Awards & highlights

Study Summary

This trial will examine the effects of puberty blockers on bone marrow composition in transgender youth.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated in the provided information, common side effects of GnRH agonists may include injection site reactions, hot flashes, headaches, mood swings and reduced bone density over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My body is in the early to middle stages of puberty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline compared to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline compared to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Bone marrow adiposity by magnetic resonance imaging (MRI) from baseline compared to 24 months
Change from magnetic resonance spectroscopy (MRS) from baseline compared to 24 months
Secondary outcome measures
Change from hip BMD Z-score by DXA from baseline compared to 24 months
Change from section modulus (bone bending strength) by quantitative computed tomography (pQCT) from baseline compared to 24 months
Change from spine BMD Z-score by DXA from baseline compared to 24 months
+2 more
Other outcome measures
Change from anxiety from baseline compared to 24 months
Change from depression from baseline compared to 24 months
Change from health-related quality of life (HRQL) from baseline compared to 24 months

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transgender ParticipantExperimental Treatment1 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 ParticipantActive Control1 Intervention
Cisgender children Tanner II or early Tanner III between 9 and 14 matched by race, age, and BMI.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,511 Total Patients Enrolled
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,650 Total Patients Enrolled

Media Library

GnRH Agonist (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04203381 — N/A
Puberty Research Study Groups: Transgender Participant, Cisgender Control Participant
Puberty Clinical Trial 2023: GnRH Agonist Highlights & Side Effects. Trial Name: NCT04203381 — N/A
GnRH Agonist (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04203381 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to adults who have reached the legal age of majority?

"The age range for participants in this study is between 9 and 14 years old."

Answered by AI

How many participants are being recruited for this clinical research?

"Affirmative, information on clinicaltrials.gov declares that this medical experiment is actively enrolling participants. It was first posted in September 15th 2020 and most recently updated on the 8th of September 2022. The study requires 80 volunteers from two separate locations."

Answered by AI

What aims is this exploration trying to accomplish?

"The primary objective of this research project, which will be monitored for a period extending from the Baseline to 12 months, is assessing bone marrow adiposity through MRI. The secondary outcomes include measuring Lumbar spine BMD Z-score using DXA and Hip bone mineral density (g/cm2) as well as Volumetric bone mineral density (vBMD) via pQCT scans acquired at 3%, 38%, and 66% of tibial length proximal to the distal growth plate."

Answered by AI

Could individuals still enroll in this clinical experiment?

"This clinical trial, initially published on September 15th 2020, is actively seeking participants. Data hosted on clinicaltrials.gov was last updated on September 8th 2022."

Answered by AI

What criteria must individuals fulfill to be eligible for this medical research?

"This trial is seeking 80 participants aged between 9 and 14 who are currently undergoing puberty. Eligible candidates must have visited either the BCH Transgender Clinic or CCHMC Transgender Clinic, be within 6 weeks of initiation pubertal blockade treatment (i.e., using drugs such as Lupron or Vantas), willingly give informed consent/assent (with parent/guardian permission necessary if applicable) , display a Tanner Stage II/III, fit into the age bracket associated with their assigned gender at birth (AMAB: 9-14 years old; AFAB: 9-13 years old), match controls in terms of race/"

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Utah
How old are they?
18 - 65
What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Cincinnati Children's Hospital Medical Center: < 48 hours
Average response time
  • < 2 Days
~16 spots leftby Mar 2025