Contraception
Conditions
Keywords
long-acting contraception,, unintended pregnancy, satisfaction, bleeding profile, amenorrhea
Brief summary
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.
Interventions
DRUGKyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice * Written informed consent.
Exclusion criteria
* Contraindications for Kyleena according to the local market authorization/SmPC * Mental incapacity to consent and provide data during the observational study * Women participating in an investigational program with interventions outside of routine clinical practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction with Kyleena assessed by questionnaire | approximately at 12 months after insertion or at premature discontinuation | The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction with Kyleena assessed by questionnaire | approximately 4-12 weeks after insertion | The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). |
| Ease of insertion assessed by investigator | Day 1 | The rating is based on the categories easy, slightly difficult, very difficult. |
| Pain at insertion assessed by participant | Day 1 | The rating is based on the categories none, mild, moderate, or severe |
| Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire | after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion | Satisfaction with the menstrual bleeding profile with Kyleena assessed by women who did and did not experience menstrual bleeding during the last three months when answering the question How satisfied were you with your menstrual bleeding pattern? respectively. The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). |
Countries
Belgium, Canada, Germany, Mexico, Norway, Spain, Sweden, United States
Outcome results
None listed