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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01320917
• Other study ID #: MIR-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 22, 2011
• Last updated: April 1, 2011
• Start date: February 2009
• Est. completion date: September 2011

Study information

• Verified date: July 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: CONEP/SISNEP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception Desired
• Obesity

Intervention

Device:
• Levonorgestrel releasing device
LNG-IUD device releases levonorgestrel in circulation
• Cu-IUD insertion
The action of a Cu-IUD does not release any hormonal compound

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia	Ribeirao Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial function and structure	Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index	6 and 12 months of following	Yes