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Completed

NCT Number: NCT03493295

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

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.

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Key information

Conditions

Contraception

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS

    Time frame: 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 outcomes

  1. 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

    Time frame: 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".

  2. 8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS

    Time frame: 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.

  3. 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)

  4. Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS

    Time frame: 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"

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

    Time frame: At 4-12 weeks after insertion

  6. Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult"

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

    Ease of LNG-IUS insertion assessed by the investigator.

  7. 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"

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

    Pain at LNG-IUS insertion assessed by the user.

  8. Percentage of women that would recommend a LNG-IUS to peers

    Time frame: At approximately 12 months

    Response in recommendation to peers item at final visit.

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

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

  10. Descriptive analysis of demographic data

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

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

  11. Reasons for withdrawal

    Time frame: Up to approximately 12 months

  12. Percentage of withdrawal

    Time frame: Up to approximately 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: BERTA

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 10, 2018
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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