Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in headache burden
研究概览
简要总结
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.
详细描述
This will be conducted at Childrens Hospital Colorado (CHCO) Clinical & Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider.
Visits will be in the morning to capture peak hormone levels.
The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure).
The daily headache diary is tailored to be brief on days when no headache occurs, and to capture more detail including medications taken and headache and aura characteristics on days a headache does occur.
The medical chart will be reviewed for relevant health information and medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transmasculine and gender diverse
- •assigned female at birth
- •age 12-20 years at the time of enrollment
- •plan to start testosterone clinically in < 6 months
- •if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
排除标准
- •cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
- •known history of stroke, multiple sclerosis, or other serious neurologic condition
- •prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
- •prior diagnosis of polycystic ovarian syndrome (PCOS)
- •uncontrolled or untreated hypothyroidism
- •MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)
研究组 & 干预措施
On blocker
Transmasculine youth who will begin taking testosterone clinically in < 6 months with or without headache and who have been on pubertal blocker, a gonadotropin hormone releasing (GnRH) agonist for at least 3 months.
干预措施: Testosterone (Drug)
No blocker
Transmasculine youth who will begin taking testosterone clinically in < 6 months with or without headache and who have no history of pubertal blocker.
干预措施: Testosterone (Drug)
结局指标
主要结局
Change in headache burden
时间窗: Over the one year of the study
Change in number of headache days per month
Amygdala volume
时间窗: At the end of the one year of study
As measured by volumetric MRI
次要结局
- Headache diagnosis(At baseline visit before start of T)