Obesity Clinical Trial
Official title:
Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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