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
- Registration Number
- NCT03182140
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1134
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kyleena Kyleena Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
- Primary Outcome Measures
Name Time Method Overall satisfaction with Kyleena assessed by questionnaire 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).
- Secondary Outcome Measures
Name Time Method Ease of insertion assessed by investigator Day 1 The rating is based on the categories easy, slightly difficult, very difficult.
Pain at insertion assessed by participant Day 1 The rating is based on the categories none, mild, moderate, or severe
Overall satisfaction with Kyleena assessed by questionnaire 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).
Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire 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).
Trial Locations
- Locations (13)
Visions Clinical Research
🇺🇸Wellington, Florida, United States
Saginaw Valley Medical Research Group, LLC
🇺🇸Saginaw, Michigan, United States
Many locations
🇸🇪Multiple Locations, Sweden
Physician's Research
🇺🇸Draper, Utah, United States
Physician Care Clinical Research LLC
🇺🇸Sarasota, Florida, United States
Jennifer Grube, MD, FACOG
🇺🇸Lakewood, Colorado, United States
New England Center for Clinical Research Primacare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Lawrence OB/GYN Clinical Research, LLC
🇺🇸Lawrenceville, New Jersey, United States
Eastern Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
TMC Life Research
🇺🇸Houston, Texas, United States
Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic
🇺🇸Pleasant Grove, Utah, United States
ProHEALTH Care Associates
🇺🇸Port Jefferson, New York, United States
Radiant Research
🇺🇸Akron, Ohio, United States