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Sponsored by: |
University of Vermont |
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Information provided by: | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00584610 |
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 | Intervention |
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Blood Coagulation Disorders |
Device: Levonorgestrel-containing IUD (Mirena®) Device: Copper-containing IUD (Paraguard®) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | The Effect of a Levonorgestrel-Releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Levonorgestrel-containing intrauterine device insertion
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Device: Levonorgestrel-containing IUD (Mirena®)
Levonorgestrel-containig intrauterine device insertion
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2: Active Comparator
Copper containing intrauterine device
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Device: Copper-containing IUD (Paraguard®)
Copper-containing intrauterine device insertion
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Ages Eligible for Study: | 18 Years to 52 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Darlene Scarano, RN | 802-847-0985 | darlene.scarano@vtmednet.org |
United States, Vermont | |
University of Vermont | Recruiting |
Burlington, Vermont, United States, 05405 |
Principal Investigator: | Kristen P Wright, MD | University of Vermont |
Principal Investigator: | Julia V. Johnson, MD | University of Vermont |
Responsible Party: | University of Vermont ( Kristen Wright ) |
Study ID Numbers: | 07-211 |
Study First Received: | December 20, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00584610 |
Health Authority: | United States: Institutional Review Board |
Women's health |
Hemorrhagic Disorders Hematologic Diseases Levonorgestrel Blood Coagulation Disorders |
Vascular Diseases Copper Hemostatic Disorders |
Contraceptive Agents Therapeutic Uses Growth Substances Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Contraceptives, Oral, Synthetic Trace Elements Cardiovascular Diseases Reproductive Control Agents Micronutrients Pharmacologic Actions |