NCT06670053 Puberty, Testosterone, and Brain Development
| NCT ID | NCT06670053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Gender Identity |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-31 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain. This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first two years of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 4 visits: * before starting T * after 6 months on T * after 1 year on T * after 2 years on T At the visits, they will be asked to: * answer questions and surveys about their health * have a brain MRI done * give a small sample of blood and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.
Eligibility Criteria
Inclusion Criteria: 1. transmasculine and gender diverse 2. assigned female at birth 3. age 12-20 years at the time of enrollment 4. plan to start testosterone clinically in \< 6 months 5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment Exclusion Criteria: 1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures 2. known history of stroke, multiple sclerosis, or other serious neurologic condition 3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development 4. prior diagnosis of polycystic ovarian syndrome (PCOS) 5. uncontrolled or untreated hypothyroidism 6. MRI-specific exclusion criteria: (Weight \> 500 lbs, severe claustrophobia, certain type of metal in body)
Contact & Investigator
Jennifer Hranilovich
PRINCIPAL INVESTIGATOR
Children's Hospital Colorado
Frequently Asked Questions
Who can join the NCT06670053 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 20 Years, studying Gender Identity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670053 currently recruiting?
Yes, NCT06670053 is actively recruiting participants. Contact the research team at headache-research@childrenscolorado.org for enrollment information.
Where is the NCT06670053 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06670053 clinical trial?
NCT06670053 is sponsored by University of Colorado, Denver. The principal investigator is Jennifer Hranilovich at Children's Hospital Colorado. The trial plans to enroll 100 participants.