Clinical trial NCT01320917: Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
Official title: Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contraception Desired
Obesity
Keywords: obesity
contraceptives hormonal
levonorgestrel-releasing intrauterine device
cardiovascular risk
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Arterial function and structure
timeFrame: 6 and 12 months of following
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia
state: SP
Study officials:
References:
citation: Zueff LFN, Melo AS, Vieira CS, Martins WP, Ferriani RA. Cardiovascular risk markers among obese women using the levonorgestrel-releasing intrauterine system: A randomised controlled trial. Obes Res Clin Pract. 2017 Nov-Dec;11(6):687-693. doi: 10.1016/j.orcp.2017.06.001. Epub 2017 Jul 8.