Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- change from baseline in d-dimer
研究概览
简要总结
The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic inflammatory disease affecting 10% of women. The objective of this study is to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis: the levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog (GnRHa) leuprolide acetate.
Hypothesis:
H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is alteration in hemostatic system with the use of GnRHa or LNG-IUS
详细描述
Materials and Methods
In this randomized open-label controlled trial, 44 women with endometriosis will be randomly allocated to one of two groups: 22 women will be assigned to use LNG-IUS and 22 to use GnRHa. The assessed variables will be D-dimers, fibrinogen, prothrombin time, activated partial thromboplastin time, coagulation factors (F) II, V, VII, VIII, IX, X, and XI, antithrombin (AT), protein C, free protein S, tissue plasminogen activator (t-PA), α2-antiplasmin, thrombin-antithrombin complex, and prothrombin fragment 1+2. All variables will be assessed before treatment and six months after treatment onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •to have endometriosis
- •aged 18 to 40 years
- •Being without contraceptives for at least 3 months or with depot medroxyprogesterone acetate or GnRHa for at least 6 months at the time of randomization.
排除标准
- •obese patients with a body mass index (BMI) ≥30 kg/m2
- •diabetics
- •alcohol or drug users
- •patients currently wishing to conceive
- •patients with chronic diseases (except endometriosis)
- •patients with infectious processes
- •patients with a personal and/or family history of thromboembolic events
- •patients taking medications known to interfere with inflammation markers (such as hormonal and nonhormonal anti-inflammatory agents) within the 15 days before the study.
研究组 & 干预措施
GnRHa
GnRHa: leuprolide
干预措施: GnRHa: leuprolide (Drug)
LNG-IUS
LNG-IUS: levonorgestrel intrauterine system
干预措施: LNG-IUS: levonorgestrel intrauterine system (Drug)
结局指标
主要结局
change from baseline in d-dimer
时间窗: baseline and 6 months
to compare the change over 6 months (6 months - baseline) on d-dimer of two treatments widely prescribed to women with endometriosis, LNG-IUS and GnRHa leuprolide acetate.
次要结局
- change from baseline in Coagulation times(baseline and 6 months)
- change from baseline in procoagulatory variables(baseline and 6 months)
- Change from baseline in natural anticoagulants(baseline and 6 months)
- Change in activation of the coagulation cascade markers(baseline and 6 months)
- Change from baseline on antifibrinolytic variables(Baseline and 6 months)
研究者
Carolina Sales Vieira
Medical Doctor, PhD
University of Sao Paulo