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

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Coagulation Disorders

Intervention / Treatment
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* Device: Levonorgestrel-containing IUD (Mirena®)
* Device: Copper-containing IUD (Paraguard®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Levonorgestrel-containing intrauterine device insertion | Device: Levonorgestrel-containing IUD (Mirena®)<br>* Levonorgestrel-containing intrauterine device insertion<br>* Other names: Mirena;|
| Active Comparator: 2<br>Copper containing intrauterine device | Device: Copper-containing IUD (Paraguard®)<br>* Copper-containing intrauterine device insertion<br>* Other names: Paraguard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with IUD device |  | 4 years | 
| Difference in bleeding patterns between groups |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women's health