Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Plasma Free Protein S Antigen Concentration at 6 Months
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of different routes of estradiol administration on blood clotting in transgender women starting gender-affirming hormone therapy. The main questions it aims to answer are:
Does sublingual estradiol reduce free Protein S levels compared to oral estradiol with cyproterone acetate?
Does sublingual estradiol accelerate activation of the clotting system, as measured by thrombin generation?
Researchers will compare sublingual estradiol to oral estradiol plus cyproterone acetate to see if the way estradiol is taken changes blood clotting risk.
Participants will:
Take either sublingual estradiol (2 mg daily in divided doses) or oral estradiol (2 mg daily) with cyproterone acetate (10 mg daily) for 6 months
Provide blood samples at baseline and after 6 months to measure hormone levels and clotting factors
Attend clinic visits for monitoring, including safety checks and routine laboratory tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Self-identified transgender women
- •Aged 18 to 45 years
- •Healthy individuals
- •Treatment-naïve (not previously exposed to gender-affirming hormone therapy)
- •Presenting for gender-affirming hormone therapy (GAHT)
- •Provided written informed consent
排除标准
- •Active smokers
- •Personal or family history of venous thromboembolism (VTE) or thrombophilia
- •History of malignancy in the past 5 years
- •Chronic liver disease
- •Chronic kidney disease
- •Hyperlipidemia
研究组 & 干预措施
Sublingual Estradiol
Participants receive sublingual estradiol 2 mg per day divided into 4 doses, without an anti-androgen, for 6 months.
干预措施: Estradiol (E2) (Drug)
Oral Estradiol + Cyproterone Acetate (CPA)
Participants receive oral estradiol 2 mg once daily combined with cyproterone acetate 10 mg once daily for 6 months. This represents the standard regimen used in routine care.
干预措施: Estradiol (E2) (Drug)
Oral Estradiol + Cyproterone Acetate (CPA)
Participants receive oral estradiol 2 mg once daily combined with cyproterone acetate 10 mg once daily for 6 months. This represents the standard regimen used in routine care.
干预措施: Cyproterone Acetate (Androcur, BAY94-8367) (Drug)
结局指标
主要结局
Change from Baseline in Plasma Free Protein S Antigen Concentration at 6 Months
时间窗: Baseline and 6 months after initiation of therapy
Plasma concentration of free Protein S antigen will be measured at baseline and after 6 months of treatment. A reduction of ≥20% in free Protein S is anticipated in the sublingual estradiol group, with no comparable change expected in the oral estradiol group.
次要结局
- Change in Protein C from baseline to 6 months(Baseline and 6 months after initiation of therapy)
- Change in Prothrombin Time (PT) from baseline to 6 months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Partial Thromboplastin Time (PTT) at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in International Normalized Ratio (INR) at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Thromboelastography (TEG) Reaction Time (R Time) at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Thromboelastography (TEG) Maximum Amplitude (MA) at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Thrombin Generation Assay (TGA) Lag Time at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Thrombin Generation Assay (TGA) Peak Thrombin at 6 Months(Baseline and 6 months after initiation of therapy)
- Change from Baseline in Thrombin Generation Assay (TGA) Area Under the Curve (AUC) at 6 Months(Baseline and 6 months after initiation of therapy)
研究者
Shmuel Kivity, MD
IRB Head
Tel-Aviv Sourasky Medical Center