Back to resultsThe Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
Primary Purpose
Women's Health, Blood Coagulation Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Norethindrone
Sponsored by
About this trial
This is an interventional prevention trial for Women's Health
Eligibility 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.
Sites / Locations
- University of Vermont
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00580424
Brief Title
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
Official Title
The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Vermont
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health, Blood Coagulation Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Norethindrone
Other Intervention Name(s)
Minipill
Intervention Description
Norethindrone 0.35 mg orally daily
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen P Wright, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia V Johnson, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
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