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

NCT01320917 | Unknown Phase 4

• 1 other identifier: MIR-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception Desired; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Levonorgestrel releasing device DEVICE

LNG-IUD device releases levonorgestrel in circulation

LNG-IUS

Cu-IUD insertion DEVICE

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

Cu-IUD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28693985 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 4, 2011

Record last verified: 2009-07

Locations

BR (1)