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

Primary Purpose

Contraception Desired, Obesity

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Levonorgestrel releasing device

Cu-IUD insertion

About this trial

This is an interventional treatment trial for Contraception Desired focused on measuring obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LNG-IUS

Cu-IUD

Arm Description

Insertion of a LNG-IUS device

Insertion of a Cu-IUD

Outcomes

Primary Outcome Measures

Arterial function and structure

Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index

Secondary Outcome Measures

Full Information

NCT ID

NCT01320917

First Posted

March 22, 2011

Last Updated

April 1, 2011

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01320917

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contraception Desired, Obesity

Keywords

obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LNG-IUS

Arm Type

Active Comparator

Arm Description

Insertion of a LNG-IUS device

Arm Title

Cu-IUD

Arm Type

Placebo Comparator

Arm Description

Insertion of a Cu-IUD

Intervention Type

Device

Intervention Name(s)

Levonorgestrel releasing device

Intervention Description

LNG-IUD device releases levonorgestrel in circulation

Intervention Type

Device

Intervention Name(s)

Cu-IUD insertion

Intervention Description

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

Primary Outcome Measure Information:

Title

Arterial function and structure

Description

Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index

Time Frame

6 and 12 months of following

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14049900

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

28693985

Citation

Zueff LFN, Melo AS, Vieira CS, Martins WP, Ferriani RA. Cardiovascular risk markers among obese women using the levonorgestrel-releasing intrauterine system: A randomised controlled trial. Obes Res Clin Pract. 2017 Nov-Dec;11(6):687-693. doi: 10.1016/j.orcp.2017.06.001. Epub 2017 Jul 8.

Results Reference

derived

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

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