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:

NCT03182140

EudraCT Number:

Not Available

Study Completed

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
1134
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Kyleena (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Germany

Status
Recruiting
 
Locations

Many locations

Many locations, Canada

Status
Recruiting
 
Locations

Many locations

Many locations, Belgium

Status
Recruiting
 
Locations

Many locations

Many locations, Sweden

Status
Recruiting
 
Locations

Many locations

Many locations, Norway

Status
Recruiting
 
Locations

Many locations

Many locations, Mexico

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Spain

Status
Not yet recruiting
 
Locations

Visions Clinical Research

Wellington, United States, 33414

Status
Recruiting
 
Locations

Physician's Research

Draper, United States, 84020

Status
Recruiting
 
Locations

ProHEALTH Care Associates

Port Jefferson, United States, 11777

Status
Recruiting
 
Locations

TMC Life Research

Houston, United States, 77054

Status
Recruiting
 
Locations

Eastern Carolina Women's Center

New Bern, United States, 28562

Status
Recruiting
 
Locations

Lawrence OB/GYN Clinical Research, LLC

Lawrenceville, United States, 08648

Status
Recruiting
 
Locations

Saginaw Valley Medical Research Group, LLC

Saginaw, United States, 48604

Status
Recruiting
 
Locations

Physician's Research Options LLC - Revere Women's Health OB/GYN Clinic

Pleasant Grove, United States, 84062

Status
Recruiting
 
Locations

New England Center for Clinical Research Primacare Research, LLC

Fall River, United States, 02721

Status
Recruiting
 
Locations

Radiant Research

Akron, United States, 44311

Status
Not yet recruiting
 
Locations

Physician Care Clinical Research LLC

Sarasota, United States, 34239

Status
Not yet recruiting
 
Locations

Jennifer Grube, MD, FACOG

Lakewood, United States, 80228

Status
Recruiting
 

Trial Design