NCT00584610

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

4.6 years

First QC Date

December 20, 2007

Last Update Submit

January 15, 2010

Conditions

Blood Coagulation Disorders

Keywords

Women's health

Outcome Measures

Primary Outcomes (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.

    4 years

Secondary Outcomes (2)

  • Patient satisfaction with IUD device

    4 years

  • Difference in bleeding patterns between groups

    4 years

Study Arms (2)

1

EXPERIMENTAL

Levonorgestrel-containing intrauterine device insertion

Device: Levonorgestrel-containing IUD (Mirena®)

2

ACTIVE COMPARATOR

Copper containing intrauterine device

Device: Copper-containing IUD (Paraguard®)

Interventions

Levonorgestrel-containing IUD (Mirena®)DEVICE

Levonorgestrel-containing intrauterine device insertion

Also known as: Mirena
1
Copper-containing IUD (Paraguard®)DEVICE

Copper-containing intrauterine device insertion

Also known as: Paraguard
2

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who desire long-term, reversible contraception

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

RECRUITING

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kristen P Wright, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Julia V. Johnson, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Penny Fairhurst, RN

CONTACT

802-847-0985penny.fairhurst@vtmednet.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

US(1)