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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by University of Sao Paulo.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01320917

First received: March 22, 2011

Last updated: April 1, 2011

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2011
Last Updated Date	April 1, 2011
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2011)	Arterial function and structure [ Time Frame: 6 and 12 months of following ] [ Designated as safety issue: Yes ] Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01320917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
Official Title ^ICMJE	Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Contraception Desired Obesity
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: LNG-IUS Insertion of a LNG-IUS device Intervention: Device: Levonorgestrel releasing device Placebo Comparator: Cu-IUD Insertion of a Cu-IUD Intervention: Device: Cu-IUD insertion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	88
Estimated Completion Date	September 2011
Estimated Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01320917
Other Study ID Numbers ^ICMJE	MIR-01
Has Data Monitoring Committee	No
Responsible Party	Rui Alberto Ferriani, University of Sao Paulo
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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