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

Completed

• Conditions: Contraception
• Interventions: Drug: Levonogestrel IntraUterine System (LNG-IUS)

• Registration Number: NCT03493295
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-10
• Study Start: 2018-04-25
• Primary Completion: 2020-11-30
• Study Completion: 2021-03-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 587

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levonogestrel IntraUterine System (LNG-IUS)	Levonogestrel IntraUterine System (LNG-IUS)	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

Primary Outcome Measures

Name	Time	Method
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS	At approximately 12 months(end of observation/final visit)	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"

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.	At 4-12 weeks after insertion
Percentage of withdrawal	Up to approximately 12 months
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	At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit)	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".
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS	At 4-12 weeks after insertion	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"
Descriptive analysis of demographic data	At initial visit (Day 0_LNG-IUS insertion)	Women's profile defined by their sociodemographic and gynaecological characteristics.
Reasons for withdrawal	Up to approximately 12 months
Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult"	At initial visit (Day 0_LNG-IUS insertion)	Ease of LNG-IUS insertion assessed by the investigator.
Percentage of women that would recommend a LNG-IUS to peers	At approximately 12 months	Response in recommendation to peers item at final visit.
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"	At initial visit (Day 0_LNG-IUS insertion)	Pain at LNG-IUS insertion assessed by the user.
8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS	At approximately 12 months(end of observation/final visit)	Overall satisfaction with the menstrual bleeding profile with LNG-IUS at 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)
Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item	At initial visit (Day 0_LNG-IUS insertion)

Trial Locations

Locations (1)

Many locations; 🇪🇸 Multiple Locations, Spain