Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern

Study Overview
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Brief Summary
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The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status. Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.

Official Title
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Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonogestrel IntraUterine System (LNG-IUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in childbearing age, between 18-30 years old. Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options. Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding. Women with no desire to conceive for at least within the next 12 months. Women capable of reading and writing Exclusion Criteria: Women whose main reason to use a LNG-IUS is not a contraceptive reason. Women with contraindication for LNG-IUS. Women with previous experience with a IUS. Women who have been diagnosed with heavy menstrual bleeding. Women with degenerative or other kind of diseases that could directly negatively impact their daily life. Women who have undergone a hysterectomy or irreversible contraceptive method. Women participating in a clinical trial. Women with a mental illness and unable to make decisions and follow instructions. Women with amenorrhea Women with clinical history of severe dysmenorrhea Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

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 |
| --- | --- |
| Levonogestrel IntraUterine System (LNG-IUS)<br>Women in childbearing age between 18 to 30 years old and who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at the routine clinical practice setting in Spain | Drug: Levonogestrel IntraUterine System (LNG-IUS)<br>* At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS | Overall satisfaction with LNG-IUS at end of observation/final visit (i.e. after approximately 12 months or at premature discontinuation). 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling very dissatisfied / very satisfied | At approximately 12 months(end of observation/final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale of overall satisfaction with the menstrual bleeding profile with LNG-IUS | Overall satisfaction rate with LNG-IUS at end of observation/final visit. 5 point Likert scale of overall satisfaction with the menstrual bleeding pattern with LNG-IUS with end labelling very dissatisfied / very satisfied. | At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit) | 
| 8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS | Overall satisfaction with the menstrual bleeding profile with LNG-IUS at end of observation/final visit. | At approximately 12 months(end of observation/final visit) | 
| Spearman's correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding pattern |  | At approximately 12 months(end of observation/final visit) | 
| Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS | Overall satisfaction with LNG-IUS 4-12 weeks after insertion. 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling very dissatisfied / very satisfied | At 4-12 weeks after insertion | 
| Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion. |  | At 4-12 weeks after insertion | 
| Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of easy, slightly difficult, very difficult | Ease of LNG-IUS insertion assessed by the investigator. | At initial visit (Day 0_LNG-IUS insertion) | 
| Pain at LNG-IUS insertion will be assessed by the clinician asking to the user on a ordinal scale of none, mild, moderate or severe | Pain at LNG-IUS insertion assessed by the user. | At initial visit (Day 0_LNG-IUS insertion) | 
| Percentage of women that would recommend a LNG-IUS to peers | Response in recommendation to peers item at final visit. | At approximately 12 months | 
| Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item |  | At initial visit (Day 0_LNG-IUS insertion) | 
| Descriptive analysis of demographic data | Women's profile defined by their sociodemographic and gynaecological characteristics. | At initial visit (Day 0_LNG-IUS insertion) | 
| Reasons for withdrawal |  | Up to approximately 12 months | 
| Percentage of withdrawal |  | Up to approximately 12 months |