Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women

Conditions
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Contraception Desired, Obesity

Intervention / Treatment
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* Device: Levonorgestrel releasing device
* Device: Cu-IUD insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LNG-IUS<br>Insertion of a LNG-IUS device | Device: Levonorgestrel releasing device<br>* LNG-IUD device releases levonorgestrel in circulation<br>|
| Placebo Comparator: Cu-IUD<br>Insertion of a Cu-IUD | Device: Cu-IUD insertion<br>* The action of a Cu-IUD does not release any hormonal compound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial function and structure | Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index | 6 and 12 months of following | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk