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

March 22, 2011
April 1, 2011
February 2009
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01320917 on ClinicalTrials.gov Archive Site
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Not Provided
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Contraception Desired
  • Obesity
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
88
September 2011
July 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01320917
MIR-01
No
Rui Alberto Ferriani, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP