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

Bayer1,134 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,134

Conditions

Contraception

Interventions

KyleenaDRUG

Kyleena - intrauterine delivery system containing 19.5 mg LNG

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (19)

Jennifer Grube, MD, FACOG

Lakewood, Colorado, United States

Physician Care Clinical Research LLC

Sarasota, Florida, United States

Outcomes

Primary Outcomes

Overall satisfaction with Kyleena assessed by questionnaire

The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).

Time frame: approximately at 12 months after insertion or at premature discontinuation

Secondary Outcomes

Overall satisfaction with Kyleena assessed by questionnaire

The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).

Time frame: approximately 4-12 weeks after insertion

Ease of insertion assessed by investigator

The rating is based on the categories easy, slightly difficult, very difficult.

Time frame: Day 1

Pain at insertion assessed by participant

The rating is based on the categories none, mild, moderate, or severe

Time frame: Day 1

Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire

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).

Time frame: after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion

Data from ClinicalTrials.gov

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