Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|