Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Arterial function and structure
研究概览
简要总结
Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS.
To assess the effects on arterial function and structure and hemostatic parameters using an levonorgestrel intrauterine device (IUS-LNG) in women with obesity
A randomized controlled clinical trial.
详细描述
Setting: Academic hospital.
88 women between 18 and 40 years of age with obesity (BMI between 20 and 40 kg/m2)randomized to use IUS-LNG or Copper-IUD for 12 months
Exclusion criteria: category 3 and 4 Medical Eligibility Criteria for IUD-Cu and IUS-LNG - WHO-2010, pregnancy, lactation, concomitant drugs, smoking.
Main Outcome Measures: Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers of cardiovascular disease and hemostatic parameters will be also analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive
排除标准
- •any clinical conditions corresponding to category 3 or 4 of the World Health Organization medical eligibility criteria for IUD-LNG or IUD-CU use smoking
- •alcoholism
- •illicit drug use
- •any systemic disease (systemic arterial hypertension, DM, immune system diseases or thyroid diseases) except PCOS
- •current or previous (up to two months before the study) use of oral, vaginal, monthly injectable or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant or intrauterine device)
- •twelve weeks or less since childbirth
- •currently breastfeeding or had stopped breastfeeding within two months of the screening visit
- •chronic and/or acute inflammatory processes
- •use of drugs known to interfere with inflammatory markers or with CVD risk (anti-androgens, hypoglycemic drugs, anti-inflammatory drugs or statins)
结局指标
主要结局
Arterial function and structure
时间窗: 6 and 12 months of following
Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
次要结局
未报告次要终点