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.
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
FemaleAge
18 - N/ATrial summary
Enrollment Goal
61448Trial Dates
October 2006 - February 2016Phase
N/ACould I Receive a placebo
N/AProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Poland | |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
Trial Type
ObservationalIntervention Type
N/ATrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A