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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01320917

Collaborator

(none)

Enrollment

Location

Arms

30.9

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Desired Obesity	Device: Levonorgestrel releasing device Device: Cu-IUD insertion	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Arterial function and structure [6 and 12 months of following]
Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)