Contraception DesiredPhase 4NCT01320917
Levonorgestrel-releasing Intrauterine Device on Obese Women: Effects on Hemostatic and Arterial Function
A Phase 4 study testing Levonorgestrel releasing device and Cu-IUD insertion in people with Contraception Desired and Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Desired, Obesity
- What is being tested?
- Levonorgestrel releasing device and Cu-IUD insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Sep 2011
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive
Who cannot join
- any clinical conditions corresponding to category 3 or 4 of the World Health Organization medical eligibility criteria for IUD-LNG or IUD-CU use smoking
- alcoholism
- illicit drug use
- any systemic disease (systemic arterial hypertension, DM, immune system diseases or thyroid diseases) except PCOS
- current or previous (up to two months before the study) use of oral, vaginal, monthly injectable or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant or intrauterine device)
- twelve weeks or less since childbirth
Show all 9Show fewer
- currently breastfeeding or had stopped breastfeeding within two months of the screening visit
- chronic and/or acute inflammatory processes
- use of drugs known to interfere with inflammatory markers or with CVD risk (anti-androgens, hypoglycemic drugs, anti-inflammatory drugs or statins)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas de Ribeirao Preto, Departamento Ginecologia e Obstetricia
Ribeirão Preto, São Paulo, 14049900
About this study
Official title: Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS.
To assess the effects on arterial function and structure and hemostatic parameters using an levonorgestrel intrauterine device (IUS-LNG) in women with obesity
A randomized controlled clinical trial.
Read the detailed description
Setting: Academic hospital.
88 women between 18 and 40 years of age with obesity (BMI between 20 and 40 kg/m2)randomized to use IUS-LNG or Copper-IUD for 12 months
Exclusion criteria: category 3 and 4 Medical Eligibility Criteria for IUD-Cu and IUS-LNG - WHO-2010, pregnancy, lactation, concomitant drugs, smoking.
Main Outcome Measures: Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers of cardiovascular disease and hemostatic parameters will be also analyzed.
- Conditions
- Contraception Desired, Obesity
- Being tested
- Levonorgestrel releasing device, Cu-IUD insertion
- Keywords
- obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel releasing deviceDevice
LNG-IUD device releases levonorgestrel in circulation
Cu-IUD insertionDevice
The action of a Cu-IUD does not release any hormonal compound
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS | Active comparator | Insertion of a LNG-IUS device Receives: Device: Levonorgestrel releasing device |
| Cu-IUD | Placebo comparator | Insertion of a Cu-IUD Receives: Device: Cu-IUD insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial function and structure
Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
Measured: 6 and 12 months of following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startFeb 2009
- Primary completionJul 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraception DesiredStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320917
- Sponsor's protocol ID
- MIR-01
- Status last verified
- Jul 2009
- First submitted
- 22 Mar 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zueff LFN, Melo AS, Vieira CS, Martins WP, Ferriani RA. Cardiovascular risk markers among obese women using the levonorgestrel-releasing intrauterine system: A randomised controlled trial. Obes Res Clin Pract. 2017 Nov-Dec;11(6):687-693. doi: 10.1016/j.orcp.2017.06.001. Epub 2017 Jul 8.
PubMed 28693985
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel-releasing Intrauterine Device Effects on Hemostatic and Arterial Function of Obese Women
- ClinicalTrials.gov ID
- NCT01320917
- Acronym / sponsor ID
- MIR-01
- Conditions
- Contraception Desired, Obesity
- Keywords
- obesity, contraceptives hormonal, levonorgestrel-releasing intrauterine device, cardiovascular risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 23 Mar 2011 (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.
Obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS.
To assess the effects on arterial function and structure and hemostatic parameters using an levonorgestrel intrauterine device (IUS-LNG) in women with obesity
A randomized controlled clinical trial.
Detailed description
Setting: Academic hospital.
88 women between 18 and 40 years of age with obesity (BMI between 20 and 40 kg/m2)randomized to use IUS-LNG or Copper-IUD for 12 months
Exclusion criteria: category 3 and 4 Medical Eligibility Criteria for IUD-Cu and IUS-LNG - WHO-2010, pregnancy, lactation, concomitant drugs, smoking.
Main Outcome Measures: Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers of cardiovascular disease and hemostatic parameters will be also analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-IUS | Active comparator | Device: Levonorgestrel releasing deviceInsertion of a LNG-IUS device |
| Cu-IUD | Placebo comparator | Device: Cu-IUD insertionInsertion of a Cu-IUD |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women 18 to 40 years of age with obesity grade I and II who wished to use a contraceptive
Key exclusion criteria (9 listed)
- any clinical conditions corresponding to category 3 or 4 of the World Health Organization medical eligibility criteria for IUD-LNG or IUD-CU use smoking
- alcoholism
- illicit drug use
- any systemic disease (systemic arterial hypertension, DM, immune system diseases or thyroid diseases) except PCOS
- current or previous (up to two months before the study) use of oral, vaginal, monthly injectable or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant or intrauterine device)
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 releasing deviceLNG-IUD device releases levonorgestrel in circulation | Device | LNG-IUS |
| Cu-IUD insertionThe action of a Cu-IUD does not release any hormonal compound | Device | Cu-IUD |
Primary outcome
Arterial function and structure
Time frame: 6 and 12 months of following
Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- Derived from this study: PubMed 28693985Zueff LFN, Melo AS, Vieira CS, Martins WP, Ferriani RA. Cardiovascular risk markers among obese women using the levonorgestrel-releasing intrauterine system: A randomised controlled trial. Obes Res Clin Pract. 2017 Nov-Dec;11(6):687-693. doi: 10.1016/j.orcp.2017.06.001. Epub 2017 Jul 8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel releasing device and Cu-IUD insertion in people with Contraception Desired and Obesity, run by University of Sao Paulo at 1 site in Brazil.
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 9 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 4 Apr 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Arterial function and structure (time frame: 6 and 12 months of following). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320917, which also lists 1 linked publication.
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 4 Apr 2011.