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

Blood Coagulation Disorders Clinical Trial

Official title:

The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00584610
• Other study ID #: 07-211
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 15, 2010
• Start date: December 2007
• Est. completion date: July 2012

Study information

• Verified date: January 2010
• Source: University of Vermont
• Contact: Penny Fairhurst, RN
• Phone: 802-847-0985
• Email: penny.fairhurst[@]vtmednet.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Device:
• Levonorgestrel-containing IUD (Mirena®)
Levonorgestrel-containing intrauterine device insertion
• Copper-containing IUD (Paraguard®)
Copper-containing intrauterine device insertion

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient satisfaction with IUD device		4 years	No
Secondary	Difference in bleeding patterns between groups		4 years	No