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The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00584610
Recruitment Status : Unknown
Verified January 2010 by University of Vermont.
Recruitment status was:  Recruiting
First Posted : January 2, 2008
Last Update Posted : January 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.

Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.


Condition or disease Intervention/treatment
Blood Coagulation Disorders Device: Levonorgestrel-containing IUD (Mirena®) Device: Copper-containing IUD (Paraguard®)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
Study Start Date : December 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Levonorgestrel-containing intrauterine device insertion
Device: Levonorgestrel-containing IUD (Mirena®)
Levonorgestrel-containing intrauterine device insertion
Other Name: Mirena
Active Comparator: 2
Copper containing intrauterine device
Device: Copper-containing IUD (Paraguard®)
Copper-containing intrauterine device insertion
Other Name: Paraguard


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome of this study will be change in coagulation parameters, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Patient satisfaction with IUD device [ Time Frame: 4 years ]
  2. Difference in bleeding patterns between groups [ Time Frame: 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who desire long-term, reversible contraception

Exclusion Criteria:

  • Women with coagulopathies
  • History of thrombotic events
  • Pregnancy
  • Active pelvic infection
  • Known hypersensitivity to progestin
  • Undiagnosed vaginal bleeding
  • Wilson's disease
  • Sensitivity to copper
  • Uterine anatomy that precludes insertion of an IUD
  • Women with multiple sexual partners and history within the last 5 years of alcoholism or drug abuse.
  • Additionally, women must be greater than 3 months postpartum and have had two months without oral contraceptive pills or 6 months without Depo Provera prior to enrollment.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584610


Contacts
Contact: Penny Fairhurst, RN 802-847-0985 penny.fairhurst@vtmednet.org

Locations
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Kristen P Wright, MD University of Vermont
Principal Investigator: Julia V. Johnson, MD University of Massachusetts, Worcester
More Information

Responsible Party: Kristen Wright, University of Vermont
ClinicalTrials.gov Identifier: NCT00584610     History of Changes
Other Study ID Numbers: 07-211
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: January 2010

Keywords provided by University of Vermont:
Women's health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances