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

Completed

Conditions studied: Contraception

In brief

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 facts

Study ID

NCT03182140

Run by

Bayer

People needed

1134

Starts

2017-07-06

Expected to finish

2020-03-31

Last updated by the study team

2021-03-29

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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