|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00580424 |
|
Date of registration:
|
18/12/2007 |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
|
|
Scientific title:
|
The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events |
|
Date of first enrolment:
|
December 2007 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00580424 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Julia V Johnson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Vermont |
|
|
Name:
|
Kristen P Wright, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Vermont |
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
52 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Blood Coagulation Disorders
|
|
Women's Health
|
|
Intervention(s)
|
|
Drug: Norethindrone
|
|
Primary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|