Recruiting

Levonorgestrel IUD vs. Copper IUD

Sponsor:

University of Vermont

Code:

NCT00584610

Conditions

Blood Coagulation Disorders

Eligibility Criteria

Sex: Female

Age: 18 - 52

Healthy Volunteers: Accepted

Interventions

Levonorgestrel-containing IUD (Mirena®)

Copper-containing IUD (Paraguard®)

Study Details

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.

Conditions

Blood Coagulation Disorders

Study ID

NCT00584610

Start date

Dec, 2007

Status verified date

Jan, 2010

Completion date

Jul, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 52

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

Levonorgestrel-containing intrauterine device insertion

active comparator: 2

Copper containing intrauterine device

Interventions

Levonorgestrel-containing IUD (Mirena®)

Levonorgestrel-containing intrauterine device insertion

Copper-containing IUD (Paraguard®)

Copper-containing intrauterine device insertion

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 ]

Central Contacts and Locations

Central contacts

Penny Fairhurst, RN

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

Locations

University of Vermont

Recruiting

Burlington, Vermont, United States, 05405

More Information

Sponsor

University of Vermont

Last update posted

Jan 18, 2010

Last verified

Jan, 2010

Keywords

  • Women's health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Vermont on 2010-01-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.