The Effect of the Mini-Pill on Blood Factors in Women at Increased Risk for Forming Blood Clots - Full Text View

Sponsored by:	University of Vermont
Information provided by:	University of Vermont
ClinicalTrials.gov Identifier:	NCT00580424

Purpose

We propose a prospective cohort study to assess the effect of the progesterone only contraceptive pill (minipill) on coagulation parameters known to be associated with risk of thrombosis (blood clots) in women who are at increased risk for forming blood clots. We plan to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein) and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception.

Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to starting the minipill), one and three months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S, fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio (nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment. This exam and the blood testing will be provided free of charge. Patients will not be prescribed the minipill after completion of the study and will be advised to consult with their primary care physician or hematologist if they wish to continue this medication.

Condition	Intervention
Women's Health Blood Coagulation Disorders	Drug: Norethindrone

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Women's Health

Drug Information available for: Norethindrone acetate Norethindrone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment
Official Title:	The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events

Further study details as provided by University of Vermont:

Primary Outcome Measures:

The primary outcome of this study will be change in coagulation parameters. The proposed sample size of 20 subjects was derived based on having sufficient power to detect a 40% change in the variable D-dimer, a lab measurement. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2009

Intervention Details:

Norethindrone 0.35 mg orally daily

Eligibility

Ages Eligible for Study:	18 Years to 52 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with a history of venous thromboembolism (VTE, blood clot in a vein) and women with a history of blood tests which demonstrate an increased risk of thrombosis who desire contraception.
Blood tests which demonstrate an increased risk of thrombosis include the following:
- Hyperhomocysteinemia/MTHFR mutation
- Prothrombin gene mutation
- Factor V Leiden heterozygotes
- Factor V Leiden homozygotes, antithrombin III mutation
- Protein S deficiency and Protein C deficiency.

Exclusion Criteria:

Women on current anticoagulation therapy
Women with a history of oral contraceptive related thrombotic events
Active or history of cigarette smoking within the past 6 months
Pregnancy
Active lactation
Known hypersensitivity to progestin
Any history of malignancy
History within the last three months of surgery or planning surgery during the study period
Undiagnosed vaginal bleeding
Active liver disease 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 contraceptive hormones (such as the birth control pill) and 6 months without Depo-Provera use prior to enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580424

Contacts

Contact: Donna LeBlanc, RN

802-847-0985

donna.leblanc@vtmednet.org

Locations

United States, Vermont
University of Vermont	Recruiting
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 Vermont

More Information

No publications provided

Responsible Party:	University of Vermont ( Kristen Wright, MD )
Study ID Numbers:	08-002
Study First Received:	December 18, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00580424 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hemorrhagic Disorders
Contraceptive Agents
Norethindrone
Hematologic Diseases
Blood Coagulation Disorders

Contraceptives, Oral
Contraceptive Agents, Female
Vascular Diseases
Hemostatic Disorders
Norethindrone acetate

Additional relevant MeSH terms:

Hematologic Diseases
Contraceptive Agents
Blood Coagulation Disorders
Physiological Effects of Drugs
Contraceptives, Oral
Vascular Diseases
Contraceptive Agents, Female
Reproductive Control Agents

Hemostatic Disorders
Pharmacologic Actions
Hemorrhagic Disorders
Norethindrone
Therapeutic Uses
Contraceptives, Oral, Synthetic
Cardiovascular Diseases
Norethindrone acetate

ClinicalTrials.gov processed this record on May 07, 2009