check_circleStudy Completed

Uterine perforation

Bayer Identifier:

13761

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
European Active Surveillance Study for Intrauterine Pessarie

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • The EURAS IUD study participants were women age 18 years or older who had a new IUD inserted at study entry.

Trial summary

Enrollment Goal
61448
Trial Dates
October 2006 - February 2016
Phase
N/A
Could I Receive a placebo
N/A
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Berlin, 10115, Germany
Completed
United Kingdom
Completed
Poland
Withdrawn
Poland
Completed
Sweden
Completed
Austria
Completed
Finland

Primary Outcome

  • Risk ratio for Uterine perforation (RR) between LNG-IUS and Copper IUD

Trial design

European Active Surveillance Study for Intrauterine Devices (EURAS-IUD)
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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