Trial Condition(s):
Contraception
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)
Bayer Identifier:
19186
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Germany | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Canada | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Belgium | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Sweden | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Norway | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Mexico | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Many locations Many locations, Spain | Status Not yet recruiting | Contact Us: E-mail: clinical-tria[email protected] Phone: (+) 1-888-8422937 |
Locations Visions Clinical Research Wellington, United States, 33414 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physician's Research Draper, United States, 84020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ProHEALTH Care Associates Port Jefferson, United States, 11777 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations TMC Life Research Houston, United States, 77054 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lawrence OB/GYN Clinical Research, LLC Lawrenceville, United States, 08648 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saginaw Valley Medical Research Group, LLC Saginaw, United States, 48604 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic Pleasant Grove, United States, 84062 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations New England Center for Clinical Research Primacare Research, LLC Fall River, United States, 02721 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Radiant Research Akron, United States, 44311 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physician Care Clinical Research LLC Sarasota, United States, 34239 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jennifer Grube, MD, FACOG Lakewood, United States, 80228 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
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).Timeframe: 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).Timeframe: approximately 4-12 weeks after insertion
- Ease of insertion assessed by investigatorThe rating is based on the categories easy, slightly difficult, very difficult.Timeframe: Day 1
- Pain at insertion assessed by participantThe rating is based on the categories none, mild, moderate, or severeTimeframe: 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).Timeframe: after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion
Additional Information
Copyright © Bayer
Powered by
