MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study

Study Overview
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Brief Summary
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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.

Official Title
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MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>BAY 86-5028; Levonorgestrel- Intra Uterine System | Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)<br>* Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage continuation rate of LNG IUS at end of observation period. |  | 12 months | 
| Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative discontinuation rate for pregnancy |  | 12 months | 
| Cumulative discontinuation rate for other medical reasons |  | 12 months | 
| Cumulative discontinuation rate for non-medical reasons |  | 12 months | 
| Mean percentage of women with amenorrhea |  | 12 months | 
| Mean percent of women with spotting, inter-menstrual bleeding |  | 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 | 12 months | 
| Incidence rate of drug-related adverse events |  | 12 months |