Female ContraceptionMARILIANCT01833793
Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
An observational study of Female Contraception, run by Bayer at 1 site in Algeria.
Trial summary
MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. 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
- Female Contraception
- What is being tested?
- Levonorgestrel IUD (Mirena, BAY86-5028)
- How many people
- 35 participants
- Where
- 1 siteAlgeria
- Study dates
- Feb 2013to May 2015
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who have been prescribed Mirena for contraception.
Who may be able to join
- Age 19-40 years at the time of Mirena IUD insertion
- Using Mirena only for contraception indication
- Never having used the product before
- No heavy menstrual bleeding diagnosed
- Have signed informed consent to participate in this study
Who cannot join
- Nulliparous
- Pregnancy
- Mirena's contre-indication
- Mirena for HMB
- Abnormal bleeding pattern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.
- Conditions
- Female Contraception
- Being tested
- Levonorgestrel IUD (Mirena, BAY86-5028)
- Keywords
- Mirena, Contraception, Amenorrhea
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUD (Mirena, BAY86-5028)Drug
Women who have been prescribed Mirena in contraception; followed up for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel IUD (Mirena, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
Measured: 12 months
Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
Measured: 12 months
Secondary outcomes (3)
Proportion of Mirena users who have menstrual disorders
Measured: 12 months
Proportion of Mirena users with menorrhagia
Measured: 12 months
Cumulative rate of satisfaction in Mirena users
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 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
- NCT01833793
- Sponsor's protocol ID
- 16314
- Other IDs
- MA1211DZ
- Acronym
- MARILIA
- Status last verified
- Sep 2015
- First submitted
- 13 Mar 2013
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
- ClinicalTrials.gov ID
- NCT01833793
- Acronym / sponsor ID
- MARILIA / 16314
- Conditions
- Female Contraception
- Keywords
- Mirena, Contraception, Amenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Apr 2013 (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.
MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel IUD (Mirena, BAY86-5028) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who have been prescribed Mirena for contraception.
Key inclusion criteria (5 listed)
- Age 19-40 years at the time of Mirena IUD insertion
- Using Mirena only for contraception indication
- Never having used the product before
- No heavy menstrual bleeding diagnosed
- Have signed informed consent to participate in this study
Key exclusion criteria (5 listed)
- Nulliparous
- Pregnancy
- Mirena's contre-indication
- Mirena for HMB
- Abnormal bleeding pattern
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 IUD (Mirena, BAY86-5028)Women who have been prescribed Mirena in contraception; followed up for 12 months | Drug | Group 1 |
Primary outcome
Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
Time frame: 12 months
Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
Time frame: 12 months
3 secondary outcomes
Proportion of Mirena users who have menstrual disorders
Time frame: 12 months
Proportion of Mirena users with menorrhagia
Time frame: 12 months
Cumulative rate of satisfaction in Mirena users
Time frame: 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 14 Sep 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 Female Contraception, run by Bayer at 1 site in Algeria.
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 5 inclusion and 5 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 14 Sep 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 Algeria. 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?
Proportion of Mirena users who have at least one period of Amenorrhea of at least three months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 14 Sep 2015.