Trial Condition(s):
pregnancy, unplanned
European Active Surveillance Study of LCS-12 (EURAS-LCS12)
Bayer Identifier:
16470
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 surveillanceExclusion Criteria
- Women aged 40 or older at insertion day
- Women who are currently enrolled in an interventional trial on IUD use can not participateTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Germany | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, United Kingdom | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Poland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Austria | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, France | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Sweden | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Czech Republic | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Finland | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Italy | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Spain | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
European Active Surveillance Study of LCS12
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
5
Primary Outcome
- Contraceptive failureTimeframe: within 3 years
Secondary Outcome
- Pelvic inflammatory disease (PID)Timeframe: within 3 - 5 years
- Ectopic pregnancyTimeframe: within 3 - 5 years
- Uterine perforationsTimeframe: within 3 - 5 years
- Contraceptive failure (Kyleena vs. Mirena and copper IUDs)Timeframe: within 5 years
Additional Information
Not Available
Copyright © Bayer
Powered by
