KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

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.

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Key information

Conditions

Contraception Amenorrhea Behavior Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction

Sex eligibility

Female

Study type

Observational

Primary location

Many locations, Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kyleena

Drug

Kyleena - intrauterine delivery system containing 19.5 mg LNG

Primary outcomes

Overall satisfaction with Kyleena assessed by questionnaire

Time frame: 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 outcomes

Overall satisfaction with Kyleena assessed by questionnaire

Time frame: 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

Time frame: Day 1

The rating is based on the categories easy, slightly difficult, very difficult.
Pain at insertion assessed by participant

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: KYSS

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Jun 9, 2017
Registry last updated: Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed