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NCT06670053 · ClinicalTrials.gov registry record
Puberty, Testosterone, and Brain Development
A clinical trial of Headache and Transgender, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06670053 is a study of Headache and Transgender that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 153-participant average among 35 other Headache trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06670053, a study of Headache and Transgender, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Testosterone
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-31 |
| Est. Completion | 2026-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06670053
The ClinicalTrials.gov registry entry for NCT06670053 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 153-participant average among 35 other Headache trials with a reported enrollment target (35% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Headache appearing as the primary indexed condition, and to 1 intervention - of which Testosterone is the first listed.
NCT06670053 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06670053 about?
NCT06670053 is a clinical study titled "Puberty, Testosterone, and Brain Development". 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 (fema...
What is the current status of trial NCT06670053?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-12-31. Estimated completion is 2026-12.
What conditions does trial NCT06670053 study?
This clinical trial studies the following conditions: Headache, Transgender, Gender Identity, Gender Dysphoria in Adolescents and Adults.
What interventions are being tested in trial NCT06670053?
The interventions under investigation include: Testosterone (DRUG).
Who is sponsoring clinical trial NCT06670053?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06670053 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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