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

Contraception Clinical Trial

— BERTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493295
• Other study ID #: 19704
• Status: Completed
• Start date: April 25, 2018
• Est. completion date: March 15, 2021

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: March 15, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Contraception
• Hemorrhage

Intervention

Drug:
• Levonogestrel IntraUterine System (LNG-IUS)
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.

Locations

Country	Name	City	State
Spain	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Perello Capo J, Lopez Gonzalez G, Rius-Tarruella J, Calaf Alsina J. Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):461-472. doi: 10.1080/13625187.2022.2112562. Epub 2022 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.		At 4-12 weeks after insertion
Secondary	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)
Secondary	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)
Secondary	Percentage of women that would recommend a LNG-IUS to peers	Response in recommendation to peers item at final visit.	At approximately 12 months
Secondary	Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item		At initial visit (Day 0_LNG-IUS insertion)
Secondary	Descriptive analysis of demographic data	Women's profile defined by their sociodemographic and gynaecological characteristics.	At initial visit (Day 0_LNG-IUS insertion)
Secondary	Reasons for withdrawal		Up to approximately 12 months
Secondary	Percentage of withdrawal		Up to approximately 12 months

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