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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320917

Enrollment

Registered

2011-03-23

Start date

2009-02-28

Completion date

2011-09-30

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception Desired, Obesity

Keywords

obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk

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.

Interventions

DEVICELevonorgestrel releasing device

LNG-IUD device releases levonorgestrel in circulation

DEVICECu-IUD insertion

The action of a Cu-IUD does not release any hormonal compound

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026