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

University of Vermont

Status

Unknown

Conditions

Blood Coagulation Disorders

Treatments

Device: Copper-containing IUD (Paraguard®)

Device: Levonorgestrel-containing IUD (Mirena®)

Study type

Interventional

Funder types

Other

Identifiers

NCT00584610

07-211

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 52 years old

Volunteers

Accepts Healthy Volunteers

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.