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Puberty, Testosterone, and Brain Development

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jun 2026 → Jun 2028
See other at-risk trials from University of Colorado, Denver

Record History

  1. Primary completion pushed from Jun 2026 to Jun 2028 Completion pushed from Dec 2026 to Jan 2029 · Eligibility criteria expanded, about 11 words · Study description revised · 1 more Show 4 more changesShow less
    • Completion pushed from Dec 2026 to Jan 2029
    • Eligibility criteria expanded, about 11 words
    • Study description revised
    • Site details revised
  2. Primary completion date: Nov 2030 to Jun 2026 Completion date: Nov 2030 to Dec 2026 · Start date changed from estimate of Dec 2024 to Dec 31, 2024v3 Show 2 more changesShow less
    • Completion date: Nov 2030 to Dec 2026
    • Start date changed from estimate of Dec 2024 to Dec 31, 2024
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Nov 2024 to Dec 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Nov 2024 to Dec 2024
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 year 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 3 visits: * before starting T * after 6 months on T * after 1 year 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 and for 1 month after the 1 year visit.
Trial Details
NCT Number NCT06670053
Lead Sponsor University of Colorado, Denver
Conditions Gender Identity, Gender Dysphoria in Adolescents and Adults, Headache, Transgender
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov