跨性别女性不同雌激素治疗方案的有效性和安全性 (TREAT研究):随机对照试验协议
Samuel Cortez1, Dominic Moog2, Christopher Lewis1
1Division of Pediatric Endrocinology, Department of Pediatrics, Washington University School of Medicine, St Louis, MO, United States.
JMIR research protocols
|December 22, 2023
概括
这项研究比较了对跨性别女性的雌激素给药方法.
科学领域:
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
- 跨性别者健康 跨性别者健康
背景情况:
- 目前的性别肯定激素治疗 (GAHT) 准则缺乏关于跨性别女性最佳雌激素给药途径的强有力的证据.
- 现有的指导方针通常依赖于专家意见和绝经后妇女的治疗方法.
- 由于报告的不良事件率,有必要研究跨性别女性GAHT的心脏代谢影响.
研究的目的:
- 为了评估不同17-β雌二醇给药途径 (子语言 vs 透皮) 在未经治疗的跨性别女性中抑制的疗效.
- 评估GAHT对代谢 (脂质,胰岛素抵抗) 和凝血因素的影响.
- 为了比较每天一次和每天两次的舌下雌激素疗法.
主要方法:
- 潜在的,开放的,随机的试验性临床试验.
- 三个分支:每天一次的舌下雌激素,每天两次的舌下雌激素,以及通过皮肤的雌激素,所有这些都含有螺旋.
- 参与者:18-45岁的跨性别女性发起GAHT,不包括具有特定并发症的女性.
- 结果:1个月和6个月的抑制;在基线,6个月和12个月的代谢和凝血因素.
主要成果:
- 该研究于2022年3月获得资助,招生于2022年8月结束.
- 研究于2023年7月结束,结果目前正在分析中.
- 目前没有结果可用.
结论:
- 跨性别雌激素肯定疗法 (TREAT) 研究旨在提供基于证据的GAHT建议.
- 它旨在确定最有效的17-β Estradiol疗法,以实现目标的抑制.
- 调查结果将为跨性别女性提供更安全,更有效的GAHT实践.
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