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NCT00580424 · ClinicalTrials.gov registry record · NA
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
A NA study, sponsored by University of Vermont.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT00580424 is a NA study that was terminated before completion, run by University of Vermont. The registered enrollment target is 20 participants.
The verdict
NCT00580424, a NA study, was terminated before completion, sponsored by University of Vermont.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Norethindrone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00580424
The ClinicalTrials.gov registry entry for NCT00580424 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Norethindrone is the first listed.
NCT00580424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00580424 about?
NCT00580424 is a clinical study titled "The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots". 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...
What is the current status of trial NCT00580424?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2007-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00580424?
The interventions under investigation include: Norethindrone (DRUG).
Who is sponsoring clinical trial NCT00580424?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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