Levonorgestrel-releasing Intrauterine Device on Obese Wom... | NCT01320917

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

NCT01320917

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Apr 4, 2011Estimated

Enrollment

88Estimated

Phase

Phase 4

Conditions

Contraception Desired
Obesity

Interventions

Levonorgestrel releasing device
Cu-IUD insertion

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jul 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2011

Last Update Posted Date

Apr 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LNG-IUS	Active Comparator	Insertion of a LNG-IUS device	Device: Levonorgestrel releasing device
Cu-IUD	Placebo Comparator	Insertion of a Cu-IUD	Device: Cu-IUD insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel releasing device	Device	LNG-IUD device releases levonorgestrel in circulation	LNG-IUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia		Ribeirão Preto	São Paulo	14049900	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28693985	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases