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

Patrocinadores

Patrocinador principal: University of Sao Paulo

Fuente University of Sao Paulo
Resumen breve

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.

Descripción detallada

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.

Estado general Unknown status
Fecha de inicio February 2009
Fecha de Terminación September 2011
Fecha de finalización primaria July 2011
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Arterial function and structure 6 and 12 months of following
Inscripción 88
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Levonorgestrel releasing device

Descripción: LNG-IUD device releases levonorgestrel in circulation

Etiqueta de grupo de brazo: LNG-IUS

Tipo de intervención: Device

Nombre de intervención: Cu-IUD insertion

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

Etiqueta de grupo de brazo: Cu-IUD

Elegibilidad

Criterios:

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)

Género: Female

Edad mínima: 18 Years

Edad máxima: 40 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones: Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia
Ubicacion Paises

Brazil

Fecha de verificación

July 2009

Fiesta responsable

Nombre Titulo: Rui Alberto Ferriani

Organización: University of Sao Paulo

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: LNG-IUS

Tipo: Active Comparator

Descripción: Insertion of a LNG-IUS device

Etiqueta: Cu-IUD

Tipo: Placebo Comparator

Descripción: Insertion of a Cu-IUD

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov