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

NCT03493295 | Completed

• 1 other identifier: 19704
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

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

  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 Outcomes (12)

• 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)

• 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)

• 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

  At 4-12 weeks after insertion

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

  At 4-12 weeks after insertion

Study Arms (1)

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)

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.

Levonogestrel IntraUterine System (LNG-IUS)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Spain

Location

Related 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.

  PMID: 36148980 BACKGROUND

Related Links

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 10, 2018
• Study Start: April 25, 2018
• Primary Completion: November 30, 2020
• Study Completion: March 15, 2021
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

ES (1)