check_circleStudy Completed

Contraception

Bayer Identifier:

19186

ClinicalTrials.gov Identifier:

NCT03182140

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
1134
Trial Dates
July 2017 - March 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Kyleena (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Germany
Recruiting
Many locationsMany locations, Canada
Recruiting
Many locationsMany locations, Belgium
Recruiting
Many locationsMany locations, Sweden
Recruiting
Many locationsMany locations, Norway
Not yet recruiting
Many locationsMany locations, Mexico
Not yet recruiting
Many locationsMany locations, Spain
Recruiting
Visions Clinical ResearchWellington, 33414, United States
Recruiting
Physician's ResearchDraper, 84020, United States
Recruiting
ProHEALTH Care AssociatesPort Jefferson, 11777, United States
Recruiting
TMC Life ResearchHouston, 77054, United States
Recruiting
Eastern Carolina Women's CenterNew Bern, 28562, United States
Recruiting
Lawrence OB/GYN Clinical Research, LLCLawrenceville, 08648, United States
Recruiting
Saginaw Valley Medical Research Group, LLCSaginaw, 48604, United States
Recruiting
Physician's Research Options LLC - Revere Women's Health OB/GYN ClinicPleasant Grove, 84062, United States
Recruiting
New England Center for Clinical Research Primacare Research, LLCFall River, 02721, United States
Not yet recruiting
Radiant ResearchAkron, 44311, United States
Not yet recruiting
Physician Care Clinical Research LLCSarasota, 34239, United States
Recruiting
Jennifer Grube, MD, FACOGLakewood, 80228, United States

Primary Outcome

  • 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).
    date_rangeTime Frame:
    approximately at 12 months after insertion or at premature discontinuation

Secondary Outcome

  • 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).
    date_rangeTime 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.
    date_rangeTime Frame:
    Day 1
  • Pain at insertion assessed by participant
    The rating is based on the categories none, mild, moderate, or severe
    date_rangeTime 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).
    date_rangeTime Frame:
    after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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