ContraceptionMirabelNCT01590537
Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
An observational study of Contraception, run by Bayer at 1 site in Russia.
Trial summary
This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel (Mirena, BAY86-5028) and Copper IUD
- Type of treatment
- Medical device
- How many people
- 2,348 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2011to Oct 2014
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Females who plan long-term contraception and meet criteria of inclusion and exclusion.
Who may be able to join
- Women 20-40 years old
- Parity ≥ 1 child
- Requesting long-term contraception
- Written informed consent.
Who cannot join
- in accordance with the current leaflet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).
- Conditions
- Contraception
- Being tested
- Levonorgestrel (Mirena, BAY86-5028), Copper IUD
- Keywords
- non-interventional, Mirena, Contraception, Russian Federation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Mirena, BAY86-5028)Drug
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
Copper IUDDevice
Copper device, inserted intrauterine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel (Mirena, BAY86-5028) | |
| Group 2 | Not described Receives: Device: Copper IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction of the contraception method with Mirena or Copper IUD
Measured: up to 12 months
Secondary outcomes (4)
Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD
Measured: up to 12 months
Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)
Measured: up to 12 months
Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)
Measured: up to 12 months
Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590537
- Sponsor's protocol ID
- 15508
- Other IDs
- MA1010RU
- Acronym
- Mirabel
- Status last verified
- Oct 2015
- First submitted
- 2 May 2012
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
- ClinicalTrials.gov ID
- NCT01590537
- Acronym / sponsor ID
- Mirabel / 15508
- Conditions
- Contraception
- Keywords
- non-interventional, Mirena, Contraception, Russian Federation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,348 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2012 (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 local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel (Mirena, BAY86-5028) |
| Group 2 | – | Device: Copper IUD |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females who plan long-term contraception and meet criteria of inclusion and exclusion.
Key inclusion criteria (4 listed)
- Women 20-40 years old
- Parity ≥ 1 child
- Requesting long-term contraception
- Written informed consent.
Key exclusion criteria (1 listed)
- in accordance with the current leaflet
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 (Mirena, BAY86-5028)intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel | Drug | Group 1 |
| Copper IUDCopper device, inserted intrauterine | Device | Group 2 |
Primary outcome
User satisfaction of the contraception method with Mirena or Copper IUD
Time frame: up to 12 months
4 secondary outcomes
Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD
Time frame: up to 12 months
Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)
Time frame: up to 12 months
Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)
Time frame: up to 12 months
Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site in Russia.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Oct 2015. 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 Russia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
User satisfaction of the contraception method with Mirena or Copper IUD (time frame: up to 12 months). 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 16 Oct 2015.