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

Bayer587 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

587

Conditions

Contraception

Interventions

Levonogestrel IntraUterine System (LNG-IUS)DRUG

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.

Eligibility

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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"

Time frame: At approximately 12 months(end of observation/final visit)

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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

Time frame: 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"

Time frame: At 4-12 weeks after insertion

Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At approximately 12 months

Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item

Time frame: At initial visit (Day 0_LNG-IUS insertion)

Descriptive analysis of demographic data

Women's profile defined by their sociodemographic and gynaecological characteristics.

Time frame: At initial visit (Day 0_LNG-IUS insertion)

Reasons for withdrawal

Time frame: Up to approximately 12 months

Percentage of withdrawal

Time frame: Up to approximately 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes