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
NCT ID: NCT03182140
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1134 participants
OBSERVATIONAL
2017-07-06
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kyleena
Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
Kyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG
Interventions
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Kyleena
Kyleena - intrauterine delivery system containing 19.5 mg LNG
Eligibility Criteria
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Inclusion Criteria
* Written informed consent.
Exclusion Criteria
* Mental incapacity to consent and provide data during the observational study
* Women participating in an investigational program with interventions outside of routine clinical practice.
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Jennifer Grube, MD, FACOG
Lakewood, Colorado, United States
Physician Care Clinical Research LLC
Sarasota, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
New England Center for Clinical Research Primacare Research, LLC
Fall River, Massachusetts, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, United States
ProHEALTH Care Associates
Port Jefferson, New York, United States
Eastern Carolina Women's Center
New Bern, North Carolina, United States
Radiant Research
Akron, Ohio, United States
TMC Life Research
Houston, Texas, United States
Physician's Research
Draper, Utah, United States
Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic
Pleasant Grove, Utah, 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
Countries
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References
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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.
Stovall 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.
Related Links
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Other Identifiers
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19186
Identifier Type: -
Identifier Source: org_study_id
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