account_circleRecruiting

Pregnancy, Unplanned

Bayer Identifier:

16470

ClinicalTrials.gov Identifier:

NCT02146950

EudraCT Number:

Not Available

EU CT Number:

Not Available
European Active Surveillance Study of LCS-12

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.

Key Participants Requirements

Sex

Female

Age

NaN - 39 Years
  • - 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 surveillance
  • - Women aged 40 or older at insertion day
    - Women who are currently enrolled in an interventional trial on IUD use can not participate

Trial summary

Enrollment Goal
83000
Trial Dates
June 2014 - December 2026
Phase
Phase 4
Could I Receive a placebo
N/A
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
Many locations, Germany
Recruiting
Many locations, United Kingdom
Recruiting
Many locations, Poland
Recruiting
Many locations, Austria
Recruiting
Many locations, France
Recruiting
Many locations, Sweden
Recruiting
Many locations, Czech Republic
Recruiting
Many locations, Finland
Recruiting
Many locations, Italy
Recruiting
Many locations, Spain

Primary Outcome

  • Contraceptive failure
    date_rangeTime Frame:
    within 3 years

Secondary Outcome

  • Pelvic inflammatory disease (PID)
    date_rangeTime Frame:
    within 3 - 5 years
  • Ectopic pregnancy
    date_rangeTime Frame:
    within 3 - 5 years
  • Uterine perforations
    date_rangeTime Frame:
    within 3 - 5 years
  • Contraceptive failure (Kyleena vs. Mirena and copper IUDs)
    date_rangeTime Frame:
    within 5 years

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
N/A