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
1 other identifier
observational
1,134
8 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMarch 29, 2021
March 1, 2021
2.5 years
May 19, 2017
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
approximately at 12 months after insertion or at premature discontinuation
Secondary Outcomes (4)
Overall satisfaction with Kyleena assessed by questionnaire
approximately 4-12 weeks after insertion
Ease of insertion assessed by investigator
Day 1
Pain at insertion assessed by participant
Day 1
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
Study Arms (1)
Kyleena
Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (19)
Jennifer Grube, MD, FACOG
Lakewood, Colorado, 80228, United States
Physician Care Clinical Research LLC
Sarasota, Florida, 34239, United States
Visions Clinical Research
Wellington, Florida, 33414, United States
New England Center for Clinical Research Primacare Research, LLC
Fall River, Massachusetts, 02721, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
ProHEALTH Care Associates
Port Jefferson, New York, 11777, United States
Eastern Carolina Women's Center
New Bern, North Carolina, 28562, United States
Radiant Research
Akron, Ohio, 44311, United States
TMC Life Research
Houston, Texas, 77054, United States
Physician's Research
Draper, Utah, 84020, United States
Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic
Pleasant Grove, Utah, 84062, United States
Many locations
Multiple Locations, Belgium
Many locations
Multiple Locations, Canada
Many locations
Multiple Locations, Germany
Many locations
Multiple Locations, Mexico
Many locations
Multiple Locations, Norway
Many locations
Multiple Locations, Spain
Many locations
Multiple Locations, Sweden
Related Publications (2)
Romer T, Frenz AK, Dietrich-Ott S, Fiedler A. The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena Satisfaction Study (KYSS). Arch Gynecol Obstet. 2024 May;309(5):2021-2030. doi: 10.1007/s00404-024-07421-5. Epub 2024 Feb 29.
PMID: 38421421DERIVEDStovall DW, Aqua K, Romer T, Donders G, Sordal T, Hauck B, Llata ES, Kallner HK, Salomon J, Zvolanek M, Frenz AK, Bohnke T, Bauerfeind A. Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena(R) satisfaction study. Eur J Contracept Reprod Health Care. 2021 Dec;26(6):462-472. doi: 10.1080/13625187.2021.1975268. Epub 2021 Sep 16.
PMID: 34528857DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
June 9, 2017
Study Start
July 6, 2017
Primary Completion
December 19, 2019
Study Completion
March 31, 2020
Last Updated
March 29, 2021
Record last verified: 2021-03