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

Phase 4UnknownNCT01320917

University of Sao Paulo88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contraception Desired Obesity

Interventions

Levonorgestrel releasing deviceDEVICE

LNG-IUD device releases levonorgestrel in circulation

Cu-IUD insertionDEVICE

The action of a Cu-IUD does not release any hormonal compound

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Arterial function and structure

Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index

Time frame: 6 and 12 months of following

Data from ClinicalTrials.gov

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