NCT01320917

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception Desired
• Obesity

Interventions

Type	Name	Description
DEVICE	Levonorgestrel releasing device	LNG-IUD device releases levonorgestrel in circulation
DEVICE	Cu-IUD insertion	The action of a Cu-IUD does not release any hormonal compound

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2011-03-23
• Last updated: 2011-04-04

Locations

1 site across 1 country: Brazil