check_circleStudy Completed
Contraception
Bayer Identifier:
19186
ClinicalTrials.gov Identifier:
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
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
1134Trial Dates
July 2017 - March 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Kyleena (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Germany |
Recruiting | Many locations | Many locations, Canada |
Recruiting | Many locations | Many locations, Belgium |
Recruiting | Many locations | Many locations, Sweden |
Recruiting | Many locations | Many locations, Norway |
Not yet recruiting | Many locations | Many locations, Mexico |
Not yet recruiting | Many locations | Many locations, Spain |
Recruiting | Visions Clinical Research | Wellington, 33414, United States |
Recruiting | Physician's Research | Draper, 84020, United States |
Recruiting | ProHEALTH Care Associates | Port Jefferson, 11777, United States |
Recruiting | TMC Life Research | Houston, 77054, United States |
Recruiting | Eastern Carolina Women's Center | New Bern, 28562, United States |
Recruiting | Lawrence OB/GYN Clinical Research, LLC | Lawrenceville, 08648, United States |
Recruiting | Saginaw Valley Medical Research Group, LLC | Saginaw, 48604, United States |
Recruiting | Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic | Pleasant Grove, 84062, United States |
Recruiting | New England Center for Clinical Research Primacare Research, LLC | Fall River, 02721, United States |
Not yet recruiting | Radiant Research | Akron, 44311, United States |
Not yet recruiting | Physician Care Clinical Research LLC | Sarasota, 34239, United States |
Recruiting | Jennifer Grube, MD, FACOG | Lakewood, 80228, United States |
Primary Outcome
- Overall satisfaction with Kyleena assessed by questionnaireThe 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 questionnaireThe 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 investigatorThe rating is based on the categories easy, slightly difficult, very difficult.date_rangeTime Frame:Day 1
- Pain at insertion assessed by participantThe rating is based on the categories none, mild, moderate, or severedate_rangeTime Frame:Day 1
- Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaireSatisfaction 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
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A