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The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots

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ClinicalTrials.gov Identifier: NCT00580424
Recruitment Status : Terminated
First Posted : December 24, 2007
Last Update Posted : June 28, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Women's Health Blood Coagulation Disorders Drug: Norethindrone

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
Study Start Date : December 2007
Estimated Study Completion Date : July 2009

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U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Norethindrone
    Norethindrone 0.35 mg orally daily
    Other Name: Minipill

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580424


Locations
United States, Vermont
University of Vermont
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

Responsible Party: Kristen Wright, MD, University of Vermont
ClinicalTrials.gov Identifier: NCT00580424     History of Changes
Other Study ID Numbers: 08-002
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: December 2007

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Norethindrone
Norethindrone acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs