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

NCT01320917 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2011-04-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Levonorgestrel releasing device

LNG-IUD device releases levonorgestrel in circulation

DEVICE

Cu-IUD insertion

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

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320917 on ClinicalTrials.gov