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

Sponsor

University of Vermont (Other)

Overall Status

Unknown status

CT.gov ID

NCT00584610

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Coagulation Disorders	Device: Levonorgestrel-containing IUD (Mirena®) Device: Copper-containing IUD (Paraguard®)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Levonorgestrel-containing intrauterine device insertion	Device: Levonorgestrel-containing IUD (Mirena®) Levonorgestrel-containing intrauterine device insertion Other Names: Mirena
Active Comparator: 2 Copper containing intrauterine device	Device: Copper-containing IUD (Paraguard®) Copper-containing intrauterine device insertion Other Names: Paraguard

Arm

Intervention/Treatment

Experimental: 1

Levonorgestrel-containing intrauterine device insertion

Device: Levonorgestrel-containing IUD (Mirena®)

Levonorgestrel-containing intrauterine device insertion

Other Names:

Mirena

Active Comparator: 2

Copper containing intrauterine device

Device: Copper-containing IUD (Paraguard®)

Copper-containing intrauterine device insertion

Other Names:

Paraguard

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Patient satisfaction with IUD device [4 years]
Difference in bleeding patterns between groups [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 52 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Vermont	Burlington	Vermont	United States	05405

Sponsors and Collaborators

University of Vermont

Investigators

Principal Investigator: Kristen P Wright, MD, University of Vermont
Principal Investigator: Julia V. Johnson, MD, University of Massachusetts, Worcester