Overview

This trial is active, not recruiting.

Conditions contraception desired, obesity
Treatments levonorgestrel releasing device, cu-iud insertion
Phase phase 4
Sponsor University of Sao Paulo
Start date February 2009
End date July 2011
Trial size 88 participants
Trial identifier NCT01320917, MIR-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Insertion of a LNG-IUS device
levonorgestrel releasing device
LNG-IUD device releases levonorgestrel in circulation
(Placebo Comparator)
Insertion of a Cu-IUD
cu-iud insertion
The action of a Cu-IUD does not release any hormonal compound

Primary Outcomes

Measure
Arterial function and structure
time frame: 6 and 12 months of following

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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)

Additional Information

Official title Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by University of Sao Paulo.