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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01320917
Other study ID # MIR-01
Secondary ID
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


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
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