Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
|ClinicalTrials.gov Identifier: NCT01320917|
Recruitment Status : Unknown
Verified July 2009 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : March 23, 2011
Last Update Posted : April 4, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception Desired Obesity||Device: Levonorgestrel releasing device Device: Cu-IUD insertion||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||September 2011|
Active Comparator: LNG-IUS
Insertion of a LNG-IUS device
Device: Levonorgestrel releasing device
LNG-IUD device releases levonorgestrel in circulation
Placebo Comparator: Cu-IUD
Insertion of a Cu-IUD
Device: Cu-IUD insertion
The action of a Cu-IUD does not release any hormonal compound
- Arterial function and structure [ Time Frame: 6 and 12 months of following ]Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320917
|Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia|
|Ribeirao Preto, SP, Brazil, 14049900|