Contraception
Conditions
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.
Interventions
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.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Overall satisfaction with the menstrual bleeding profile with LNG-IUS at 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 LNG-IUS 4-12 weeks after insertion. 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling very dissatisfied / very satisfied |
| 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 | At initial visit (Day 0_LNG-IUS insertion) | Ease of LNG-IUS insertion assessed by the investigator. |
| 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) | 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. |
| Percentage of women that would recommend a LNG-IUS to peers | At approximately 12 months | Response in recommendation to peers item at final visit. |
| 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 | At initial visit (Day 0_LNG-IUS insertion) | Women's profile defined by their sociodemographic and gynaecological characteristics. |
| Reasons for withdrawal | Up to approximately 12 months | — |
| Percentage of withdrawal | Up to approximately 12 months | — |
| 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 | At initial visit (Day 0_LNG-IUS insertion) | Pain at LNG-IUS insertion assessed by the user. |
Countries
Spain
Outcome results
None listed