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

University of Sao Paulo

Status and phase

Unknown

Phase 4

Conditions

Contraception Desired

Obesity

Treatments

Device: Cu-IUD insertion

Device: Levonorgestrel releasing device

Study type

Interventional

Funder types

Other

Identifiers

NCT01320917

MIR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)