Blood Coagulation DisordersNCT00584610
The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots
A study testing Levonorgestrel-containing IUD (Mirena®) and Copper-containing IUD (Paraguard®) in people with Blood Coagulation Disorders, run by University of Vermont at 1 site in United States.
Trial summary
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorders
- What is being tested?
- Levonorgestrel-containing IUD (Mirena®) and Copper-containing IUD (Paraguard®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who desire long-term, reversible contraception
Who cannot join
- Women with coagulopathies
- History of thrombotic events
- Pregnancy
- Active pelvic infection
- Known hypersensitivity to progestin
- Undiagnosed vaginal bleeding
Show all 11Show fewer
- Wilson's disease
- Sensitivity to copper
- Uterine anatomy that precludes insertion of an IUD
- Women with multiple sexual partners 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 oral contraceptive pills or 6 months without Depo Provera prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05405
About this study
Official title: The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.
Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.
- Conditions
- Blood Coagulation Disorders
- Being tested
- Levonorgestrel-containing IUD (Mirena®), Copper-containing IUD (Paraguard®)
- Keywords
- Women's health
- 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.
Levonorgestrel-containing IUD (Mirena®)Device
Also called Mirena
Levonorgestrel-containing intrauterine device insertion
Copper-containing IUD (Paraguard®)Device
Also called Paraguard
Copper-containing intrauterine device insertion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levonorgestrel-containing intrauterine device insertion Receives: Device: Levonorgestrel-containing IUD (Mirena®) |
| 2 | Active comparator | Copper containing intrauterine device Receives: Device: Copper-containing IUD (Paraguard®) |
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, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups.
Measured: 4 years
Secondary outcomes (2)
Patient satisfaction with IUD device
Measured: 4 years
Difference in bleeding patterns between groups
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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 Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584610
- Sponsor's protocol ID
- 07-211
- Status last verified
- Jan 2010
- First submitted
- 20 Dec 2007
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters
- ClinicalTrials.gov ID
- NCT00584610
- Acronym / sponsor ID
- 07-211
- Conditions
- Blood Coagulation Disorders
- Keywords
- Women's health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Jan 2008 (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.
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.
Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Levonorgestrel-containing IUD (Mirena®)Levonorgestrel-containing intrauterine device insertion |
| 2 | Active comparator | Device: Copper-containing IUD (Paraguard®)Copper containing intrauterine device |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who desire long-term, reversible contraception
Key exclusion criteria (11 listed)
- Women with coagulopathies
- History of thrombotic events
- Pregnancy
- Active pelvic infection
- Known hypersensitivity to progestin
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 |
|---|---|---|
| Levonorgestrel-containing IUD (Mirena®)Also: MirenaLevonorgestrel-containing intrauterine device insertion | Device | 1 |
| Copper-containing IUD (Paraguard®)Also: ParaguardCopper-containing intrauterine device insertion | Device | 2 |
Primary outcome
The primary outcome of this study will be change in coagulation parameters, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups.
Time frame: 4 years
2 secondary outcomes
Patient satisfaction with IUD device
Time frame: 4 years
Difference in bleeding patterns between groups
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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 Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel-containing IUD (Mirena®) and Copper-containing IUD (Paraguard®) in people with 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Penny Fairhurst, RN (802-847-0985, penny.fairhurst@vtmednet.org), or a site near the patient. 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, with sample size calculations powered to detect a 35% change in D-dimer within groups and a 50% difference between groups. (time frame: 4 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 18 Jan 2010.