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

Blood Coagulation Disorders Clinical Trial

Official title:

The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580424
• Other study ID #: 08-002
• Status: Terminated
• Phase: N/A
• First received: December 18, 2007
• Last updated: June 24, 2010
• Start date: December 2007
• Est. completion date: July 2009

Study information

• Verified date: December 2007
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Women's Health

Intervention

Drug:
• Norethindrone
Norethindrone 0.35 mg orally daily

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No