KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Study Overview
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Brief Summary
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The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.

Official Title
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KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

Conditions
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Contraception

Intervention / Treatment
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* Drug: Kyleena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice Written informed consent. Exclusion Criteria: Contraindications for Kyleena according to the local market authorization/SmPC Mental incapacity to consent and provide data during the observational study Women participating in an investigational program with interventions outside of routine clinical practice.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kyleena<br>Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study | Drug: Kyleena<br>* Kyleena - intrauterine delivery system containing 19.5 mg LNG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with Kyleena assessed by questionnaire | The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). | approximately at 12 months after insertion or at premature discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with Kyleena assessed by questionnaire | The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). | approximately 4-12 weeks after insertion | 
| Ease of insertion assessed by investigator | The rating is based on the categories easy, slightly difficult, very difficult. | Day 1 | 
| Pain at insertion assessed by participant | The rating is based on the categories none, mild, moderate, or severe | Day 1 | 
| Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire | Satisfaction with the menstrual bleeding profile with Kyleena assessed by women who did and did not experience menstrual bleeding during the last three months when answering the question How satisfied were you with your menstrual bleeding pattern? respectively. The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). | after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-acting contraception,, unintended pregnancy, satisfaction, bleeding profile, amenorrhea