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 (KYSS)

March 25, 2021 updated by: Bayer
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
        • Many locations
  • Canada
      • Multiple Locations, Canada
        • Many locations
  • Germany
      • Multiple Locations, Germany
        • Many locations
  • Mexico
      • Multiple Locations, Mexico
        • Many locations
  • Norway
      • Multiple Locations, Norway
        • Many locations
  • Spain
      • Multiple Locations, Spain
        • Many locations
  • Sweden
      • Multiple Locations, Sweden
        • Many locations
  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Jennifer Grube, MD, FACOG
    • Florida
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research LLC
      • Wellington, Florida, United States, 33414
        • Visions Clinical Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • New England Center for Clinical Research Primacare Research, LLC
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group, LLC
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB/GYN Clinical Research, LLC
    • New York
      • Port Jefferson, New York, United States, 11777
        • ProHEALTH Care Associates
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research
    • Texas
      • Houston, Texas, United States, 77054
        • TMC Life Research
    • Utah
      • Draper, Utah, United States, 84020
        • Physician's Research
      • Pleasant Grove, Utah, United States, 84062
        • Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in the respective participating country requesting contraception with Kyleena will be eligible to be enrolled.

Women can be screened for the study only after an informed decision for Kyleena has been made by the woman and the treating health care professional such as her physician/gynecologist or midwife. Indication and contraindications according to the local market authorization/ summary of product characteristics (SmPC) should be carefully considered.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kyleena
Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
Drug: Kyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
approximately at 12 months after insertion or at premature discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
approximately 4-12 weeks after insertion
Ease of insertion assessed by investigator
Time Frame: Day 1
The rating is based on the categories easy, slightly difficult, very difficult.
Day 1
Pain at insertion assessed by participant
Time Frame: Day 1
The rating is based on the categories none, mild, moderate, or severe
Day 1
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).
after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2017

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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