Women's HealthNCT00580424
The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots
A study testing Norethindrone in people with Women's Health and Blood Coagulation Disorders, run by University of Vermont at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Women's Health, Blood Coagulation Disorders
- What is being tested?
- Norethindrone
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
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.
- Conditions
- Women's Health, Blood Coagulation Disorders
- Being tested
- Norethindrone
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorethindroneDrug
Also called Minipill
Norethindrone 0.35 mg orally daily
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2007
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Investigators
- Kristen P Wright, MD, Principal investigator, University of VermontJulia V Johnson, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580424
- Sponsor's protocol ID
- 08-002
- Status last verified
- Dec 2007
- First submitted
- 18 Dec 2007
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Norethindrone on Coagulation Parameters in Women at Increased Risk for Venous Thromboembolic Events
- ClinicalTrials.gov ID
- NCT00580424
- Acronym / sponsor ID
- 08-002
- Conditions
- Women's Health, Blood Coagulation Disorders
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2007
- Study completion
- Jul 2009 (estimated)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorethindroneAlso: MinipillNorethindrone 0.35 mg orally daily | Drug | – |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen P Wright, MD principal investigator
University of Vermont
Julia V Johnson, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norethindrone in people with Women's Health and Blood Coagulation Disorders, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2010.