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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: Clinical Trial NA study, sponsored by University of Vermont.
NCT00580424 is a NA study that was terminated before completion, run by University of Vermont. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00580424 stopped before completion
NCT00580424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Norethindrone is the first listed.
NCT00580424 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00580424's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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