ContraceptionMIDASNCT01961375
MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study
An observational study of Contraception, run by Bayer at 1 site in India.
Trial summary
The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2015to 21 Sep 2023
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The study subjects will be enrolled from multiple sites like women's hospitals, tertiary care institutes, Family planning clinics and gynaecological consulting centres.
Who may be able to join
- Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
- Subject willing to provide informed consent and comply with study procedure.
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
- Conditions
- Contraception
- Being tested
- Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)Drug
Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | BAY 86-5028; Levonorgestrel- Intra Uterine System Receives: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage continuation rate of LNG IUS at end of observation period.
Measured: 12 months
Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
Measured: 12 months
Secondary outcomes (7)
Cumulative discontinuation rate for pregnancy
Measured: 12 months
Cumulative discontinuation rate for other medical reasons
Measured: 12 months
Cumulative discontinuation rate for non-medical reasons
Measured: 12 months
Mean percentage of women with amenorrhea
Measured: 12 months
Mean percent of women with spotting, inter-menstrual bleeding
Measured: 12 months
Distribution of contraceptive usage patterns
contraceptive usage patterns included:birth-spacing, long term contraception, postpartum contraception, post-abortion contraception, switch from other method, contraception for other medical reasons like heart disease, etc
Measured: 12 months
Incidence rate of drug-related adverse events
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 posted11 Oct 2013 (estimated)
- Study start30 Oct 2015
- Primary completion28 Nov 2018
- Study completion21 Sep 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 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
- NCT01961375
- Sponsor's protocol ID
- 16199
- Other IDs
- MA1210IN
- Acronym
- MIDAS
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2013
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
- ClinicalTrials.gov ID
- NCT01961375
- Acronym / sponsor ID
- MIDAS / 16199
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 11 Oct 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.
The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)BAY 86-5028; Levonorgestrel- Intra Uterine System |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study subjects will be enrolled from multiple sites like women's hospitals, tertiary care institutes, Family planning clinics and gynaecological consulting centres.
Key inclusion criteria (2 listed)
- Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
- Subject willing to provide informed consent and comply with study procedure.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information.
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- Intra Uterine System (BAY 86-5028_Mirena)Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion | Drug | Group 1 |
Primary outcome
Percentage continuation rate of LNG IUS at end of observation period.
Time frame: 12 months
Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
Time frame: 12 months
7 secondary outcomes
Cumulative discontinuation rate for pregnancy
Time frame: 12 months
Cumulative discontinuation rate for other medical reasons
Time frame: 12 months
Cumulative discontinuation rate for non-medical reasons
Time frame: 12 months
Mean percentage of women with amenorrhea
Time frame: 12 months
Mean percent of women with spotting, inter-menstrual bleeding
Time frame: 12 months
Distribution of contraceptive usage patterns
Time frame: 12 months
Incidence rate of drug-related adverse events
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 13 Oct 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 India.
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 2 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 13 Oct 2023. 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 India. 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?
Percentage continuation rate of LNG IUS at end of observation period. (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 13 Oct 2023.