Trial Condition(s):

pregnancy, unplanned

European Active Surveillance Study of LCS-12 (EURAS-LCS12)

Bayer Identifier:

16470

ClinicalTrials.gov Identifier:

NCT02146950

EudraCT Number:

Not Available

Recruiting

Trial Purpose

This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.

Inclusion Criteria
- Women aged below 40 years who have a new IUD inserted (LCS12, Mirena or copper IUD)
        - Women who are willing to participate in the active surveillance
Exclusion Criteria
- Women aged 40 or older at insertion day
        - Women who are currently enrolled in an interventional trial on IUD use can not participate

Trial Summary

Enrollment Goal
83000
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Germany

Status
Recruiting
 
Locations

Investigative Site

Many locations, United Kingdom

Status
Recruiting
 
Locations

Investigative Site

Many locations, Poland

Status
Recruiting
 
Locations

Investigative Site

Many locations, Austria

Status
Recruiting
 
Locations

Investigative Site

Many locations, France

Status
Recruiting
 
Locations

Investigative Site

Many locations, Sweden

Status
Recruiting
 
Locations

Investigative Site

Many locations, Czech Republic

Status
Recruiting
 
Locations

Investigative Site

Many locations, Finland

Status
Recruiting
 
Locations

Investigative Site

Many locations, Italy

Status
Recruiting
 
Locations

Investigative Site

Many locations, Spain

Status
Recruiting
 

Trial Design