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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01320917
First received: March 22, 2011
Last updated: April 1, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Contraception Desired
Obesity
Device: Levonorgestrel releasing device
Device: Cu-IUD insertion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Arterial function and structure [ Time Frame: 6 and 12 months of following ] [ Designated as safety issue: Yes ]
    Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index


Estimated Enrollment: 88
Study Start Date: February 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LNG-IUS
Insertion of a LNG-IUS device
Device: Levonorgestrel releasing device
LNG-IUD device releases levonorgestrel in circulation
Placebo Comparator: Cu-IUD
Insertion of a Cu-IUD
Device: Cu-IUD insertion
The action of a Cu-IUD does not release any hormonal compound

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320917

Locations
Brazil
Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia
Ribeirao Preto, SP, Brazil, 14049900
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Rui Alberto Ferriani, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01320917     History of Changes
Other Study ID Numbers: MIR-01
Study First Received: March 22, 2011
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration
Brazil: CONEP/SISNEP

Keywords provided by University of Sao Paulo:
obesity
contraceptives hormonal
levonorgestrel-releasing intrauterine device
cardiovascular risk

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hemostatics
Levonorgestrel
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 22, 2014