Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 587
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
timeFrame: At approximately 12 months(end of observation/final visit)
Secondary outcomes:
measure: 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
timeFrame: At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit)
measure: 8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS
timeFrame: At approximately 12 months(end of observation/final visit)
measure: Spearman's correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding pattern
timeFrame: At approximately 12 months(end of observation/final visit)
measure: Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
timeFrame: At 4-12 weeks after insertion
measure: Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.
timeFrame: At 4-12 weeks after insertion
measure: Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult"
timeFrame: At initial visit (Day 0_LNG-IUS insertion)
measure: 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"
timeFrame: At initial visit (Day 0_LNG-IUS insertion)
measure: Percentage of women that would recommend a LNG-IUS to peers
timeFrame: At approximately 12 months
measure: Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item
timeFrame: At initial visit (Day 0_LNG-IUS insertion)
measure: Descriptive analysis of demographic data
timeFrame: At initial visit (Day 0_LNG-IUS insertion)
measure: Reasons for withdrawal
timeFrame: Up to approximately 12 months
measure: Percentage of withdrawal
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
facility: Many locations
Study officials:
References:
citation: 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.