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Trial record 49 of 403 for:    LEVONORGESTREL

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

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE January 2, 2008
Last Update Posted Date January 18, 2010
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
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 ]
Change History Complete list of historical versions of study NCT00584610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
  • Patient satisfaction with IUD device [ Time Frame: 4 years ]
  • Difference in bleeding patterns between groups [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
  • Patient satisfaction with IUD device [ Time Frame: 2 years ]
  • Difference in bleeding patterns between groups [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
Official Title  ICMJE The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Blood Coagulation Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2007)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00584610
Other Study ID Numbers  ICMJE 07-211
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristen Wright, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen P Wright, MD University of Vermont
Principal Investigator: Julia V. Johnson, MD University of Massachusetts, Worcester
PRS Account University of Vermont
Verification Date January 2010

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