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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Vermont.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00584610
First received: December 20, 2007
Last updated: January 15, 2010
Last verified: January 2010
History of Changes
  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®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters

Resource links provided by NLM:

U.S. FDA Resources

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: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with IUD device [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Difference in bleeding patterns between groups [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: 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

No publications provided

Responsible Party: Kristen Wright, University of Vermont
ClinicalTrials.gov Identifier: NCT00584610     History of Changes
Other Study ID Numbers: 07-211
Study First Received: December 20, 2007
Last Updated: January 15, 2010
Health Authority: United States: Institutional Review Board

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
Copper
Levonorgestrel
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 22, 2013