思春期、テストステロン、脳の発達
トランスマスキュリンの若者における脳画像化と頭痛に対するテストステロンの影響
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.
調査の概要
詳細な説明
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.
MR-based imaging will be conducted at the Brain Imaging Center at the University of Colorado Anschutz Medical Campus.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jennifer Hranilovich, MD
- 電話番号：(720)-777-6895
- メール：headache-research@childrenscolorado.org
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- 募集
- Children's Hospital Colorado
-
コンタクト：
- Jennifer Hranilovich
- 電話番号：720-777-6895
- メール：headache-research@childrenscolorado.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
transmasculine and gender diverse youth
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician. |
|
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. |
Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in headache burden
時間枠：Over the one year of the study
|
Change in number of headache days per month |
Over the one year of the study
|
|
Amygdala volume
時間枠：At the end of the one year of study
|
As measured by volumetric MRI |
At the end of the one year of study
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Headache diagnosis
時間枠：At baseline visit before start of T
|
Application of ICHD-3 criteria to headaches, if any |
At baseline visit before start of T
|
協力者と研究者
捜査官
- 主任研究者：Jennifer Hranilovich、Children's Hospital Colorado
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 23-1113
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。