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

Phase 4

• Conditions: Contraception Desired; Obesity
• Interventions: Device: Levonorgestrel releasing device; Device: Cu-IUD insertion

• Registration Number: NCT01320917
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study Start: 2009-02
• Status Verified: 2009-07
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04
• Primary Completion: 2011-07
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNG-IUS	Levonorgestrel releasing device	Insertion of a LNG-IUS device
Cu-IUD	Cu-IUD insertion	Insertion of a Cu-IUD

Primary Outcome Measures

Name	Time	Method
Arterial function and structure	6 and 12 months of following	Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index

Trial Locations

Locations (1)

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia; 🇧🇷 Ribeirao Preto, SP, Brazil