- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320917
Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
SP
-
Ribeirao Preto, SP, Brazil, 14049900
- Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LNG-IUS
Insertion of a LNG-IUS device
|
LNG-IUD device releases levonorgestrel in circulation
|
Placebo Comparator: Cu-IUD
Insertion of a Cu-IUD
|
The action of a Cu-IUD does not release any hormonal compound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial function and structure
Time Frame: 6 and 12 months of following
|
Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
|
6 and 12 months of following
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIR-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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