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

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception Desired; Obesity

Intervention: Levonorgestrel releasing device (Device); Cu-IUD insertion (Device)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Sao Paulo

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Arterial function and structure

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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)

Locations and Contacts

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia, Ribeirao Preto, SP 14049900, Brazil
Additional Information

Starting date: February 2009
Last updated: April 1, 2011

Page last updated: August 23, 2015

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