Trial Condition(s):
Uterine perforation
European Active Surveillance Study for Intrauterine Pessarie
Bayer Identifier:
13761
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Sweden | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Finland | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Risk ratio for Uterine perforation (RR) between LNG-IUS and Copper IUDTimeframe:
Additional Information
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