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

Information source: University of Vermont
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blood Coagulation Disorders

Intervention: Levonorgestrel-containing IUD (Mirena®) (Device); Copper-containing IUD (Paraguard®) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: University of Vermont

Official(s) and/or principal investigator(s):
Kristen P Wright, MD, Principal Investigator, Affiliation: University of Vermont
Julia V. Johnson, MD, Principal Investigator, Affiliation: University of Massachusetts, Worcester

Overall contact:
Penny Fairhurst, RN, Phone: 802-847-0985, Email: penny.fairhurst@vtmednet.org

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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

Patient satisfaction with IUD device

Difference in bleeding patterns between groups

Eligibility

Minimum age: 18 Years. Maximum age: 52 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Penny Fairhurst, RN, Phone: 802-847-0985, Email: penny.fairhurst@vtmednet.org

University of Vermont, Burlington, Vermont 05405, United States; Recruiting
Additional Information

Starting date: December 2007
Last updated: January 15, 2010

Page last updated: August 23, 2015

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