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The Effect of a Levonorgestrel-Releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
This study is currently recruiting participants.
Verified by University of Vermont, June 2008
Sponsored by: University of Vermont
Information provided by: University of Vermont
ClinicalTrials.gov Identifier: NCT00584610
  Purpose

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 Intervention
Blood Coagulation Disorders
Device: Levonorgestrel-containing IUD (Mirena®)
Device: Copper-containing IUD (Paraguard®)

Genetics Home Reference related topics: hemophilia
MedlinePlus related topics: Bleeding Disorders
Drug Information available for: Levonorgestrel
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Subject), Parallel Assignment
Official Title: The Effect of a Levonorgestrel-Releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • 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: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with IUD device [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Difference in bleeding patterns between groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Levonorgestrel-containing intrauterine device insertion
Device: Levonorgestrel-containing IUD (Mirena®)
Levonorgestrel-containig intrauterine device insertion
2: Active Comparator
Copper containing intrauterine device
Device: Copper-containing IUD (Paraguard®)
Copper-containing intrauterine device insertion

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584610

Contacts
Contact: Darlene Scarano, RN 802-847-0985 darlene.scarano@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 Vermont
  More Information

Responsible Party: University of Vermont ( Kristen Wright )
Study ID Numbers: 07-211
Study First Received: December 20, 2007
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00584610  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Women's health

Study placed in the following topic categories:
Hemorrhagic Disorders
Hematologic Diseases
Levonorgestrel
Blood Coagulation Disorders
Vascular Diseases
Copper
Hemostatic Disorders

Additional relevant MeSH terms:
Contraceptive Agents
Therapeutic Uses
Growth Substances
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Trace Elements
Cardiovascular Diseases
Reproductive Control Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009