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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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