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 (BERTA)

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 Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Levonogestrel IntraUterine System (LNG-IUS)

• Study Type: Observational
• Enrollment (Actual): 587

Contacts and Locations

Study Locations

• Spain
  • Multiple Locations, Spain
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be women in childbearing age between ≥18 to 30 years, who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at a routine visit prior to the first study visit (enrolment) in a routine clinical practice setting. Then, women eligible for the enrolment will be visiting the physician in a IUS insertion visit in a gynaecological clinical setting.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 19704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No