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

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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:
University of Vermont

December 20, 2007
January 2, 2008
January 18, 2010
December 2007
July 2012   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00584610 on ClinicalTrials.gov Archive Site
  • Patient satisfaction with IUD device [ Time Frame: 4 years ]
  • Difference in bleeding patterns between groups [ Time Frame: 4 years ]
  • Patient satisfaction with IUD device [ Time Frame: 2 years ]
  • Difference in bleeding patterns between groups [ Time Frame: 2 years ]
Not Provided
Not Provided
 
The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Blood Coagulation Disorders
  • Device: Levonorgestrel-containing IUD (Mirena®)
    Levonorgestrel-containing intrauterine device insertion
    Other Name: Mirena
  • Device: Copper-containing IUD (Paraguard®)
    Copper-containing intrauterine device insertion
    Other Name: Paraguard
  • Experimental: 1
    Levonorgestrel-containing intrauterine device insertion
    Intervention: Device: Levonorgestrel-containing IUD (Mirena®)
  • Active Comparator: 2
    Copper containing intrauterine device
    Intervention: Device: Copper-containing IUD (Paraguard®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 52 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584610
07-211
Yes
Not Provided
Not Provided
Kristen Wright, University of Vermont
University of Vermont
Not Provided
Principal Investigator: Kristen P Wright, MD University of Vermont
Principal Investigator: Julia V. Johnson, MD University of Massachusetts, Worcester
University of Vermont
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP