Is There an Effect of Local Vaginal Estrogen Treatment on the Hemostatic Parameters in Postmenopausal Women?
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Endogenous thrombin potential (ETP)
研究概览
简要总结
This study investigates whether vaginal estrogen treatment has an effect on hemostatic parameters in postmenopausal women. Blood samples are collected before and after 3 months treatment to assess changes in hemostasis.
详细描述
This prospective cohort study includes 90 postmenopausal women aged ≥ 50, having vaginal atrophy symptoms and indication for treatment with vaginal estrogen tablets 10 µg at least 3 times a week for 3 months. Participants are divided into 2 study populations. Study population 1: 45 without a history of venous thromboembolic event and study population 2: 45 with a history of venous thromboembolic event.
Participation will involve 2 visits:
- First visit: prior the initiation of treatment an interview is carried out to assess inclusion criteria and information on demographics followed by blood sampling.
- Second visit: follow-up blood sampling after three months treatment. Hemostatic parameters will be assessed, comparing the blood samples at baseline with the follow-up blood sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged ≥ 50
- •Symptomatic vaginal atrophy
- •Indication for standard treatment with vaginal estrogen tablets 10 µg at least three times a week
- •Study population 1: without a history of venous thromboembolic event
- •Study population 2: with a history of venous thromboembolic event
排除标准
- •Unable to give written informed consent
- •Does not speak Danish
- •Current cancer treatment
- •Current treatment with blood thinning medication (except plateletinhibitor)
- •Current treatment with local or systematic estrogen
- •Systemic inflammatory disease, liver disease or kidney disease
研究组 & 干预措施
Vaginal estrogen treatment
干预措施: Vaginal estradiol tablets (Drug)
结局指标
主要结局
Endogenous thrombin potential (ETP)
时间窗: 0 months, 3 months
nmol/l x min
Endogenous trombin lag time (LT)
时间窗: 0 months, 3 months
min
Endogenous trombin peak height
时间窗: 0 months, 3 months
nmol/l
Factor VIII (FVIII)
时间窗: 0 months, 3 months
Percentage
Antithrombin
时间窗: 0 months, 3 months
Percentage
Protein S
时间窗: 0 months, 3 months
Percentage
Protein C
时间窗: 0 months, 3 months
Percentage
D-dimer
时间窗: 0 months, 3 months
ng/mL
CRP
时间窗: 0 months, 3 months
mg/l
Fibrinogen
时间窗: 0 months, 3 months
g/l
Tissue-type plaminogen activator (t-PA)
时间窗: 0 months, 3 months
ng/mL
Plasminogen activator inhibitor type 1 (PAI-1)
时间窗: 0 months, 3 months
ng/mL
Faktor XII (FXII)
时间窗: 0 months, 3 months
μg/mL
Prekallikrein (PK)
时间窗: 0 months, 3 months
μg/mL
H-Kininogen (HK)
时间窗: 0 months, 3 months
Percentage
Cleaved H-Kininogen (cHK)
时间窗: 0 months, 3 months
μg/mL
C1-esterase inhibitor (C1-inh)
时间窗: 0 months, 3 months
g/L
Endogenous kallikrein potential (EKP)
时间窗: 0 months, 3 months
nmol/L x min
次要结局
未报告次要终点