Trial Condition(s):

Uterine perforation

European Active Surveillance Study for Intrauterine Pessarie

Bayer Identifier:

13761

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Primary objective(s):
Risks of Levonorgestrel-Intrauterine System ( LNG-IUS) use and copper Intrauterine Device (IUD) use in a study population that is representative of the actual users of the individual IUDs; including risk of rare serious adverse outcomes.
Secondary objective(s):
Secondary objectives included general safety, impact of postpartum state and breastfeeding on perforation risk, clinical complications of perforations and the drug utilization pattern of IUDs.

Inclusion Criteria
:
The EURAS IUD study participants were women age 18 years or older who had a new IUD inserted at study entry.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
61448
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 10115

Status
Completed
 
Locations

Investigative Site

Many locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many locations, Poland

Status
Completed
 
Locations

Investigative Site

Many locations, Sweden

Status
Completed
 
Locations

Investigative Site

Many locations, Austria

Status
Completed
 
Locations

Investigative Site

Many locations, Finland

Status
Completed
 

Trial Design