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European Active Surveillance Study of LCS12 (EURAS_LCS12)

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ClinicalTrials.gov Identifier: NCT02146950
Recruitment Status : Recruiting
First Posted : May 26, 2014
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany

Brief Summary:
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.

Condition or disease
Contraception

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 38000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Active Surveillance Study of LCS12
Actual Study Start Date : June 2014
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : December 2022

Group/Cohort
LCS12
New users of LCS12
Mirena
New users of Mirena
Copper IUD
New users of copper IUDs



Primary Outcome Measures :
  1. Unintended pregnancy [ Time Frame: within 3 years ]

Secondary Outcome Measures :
  1. Pelvic inflammatory disease (PID) [ Time Frame: within 3 years ]
  2. Ectopic pregnancy [ Time Frame: within 3 years ]
  3. Uterine perforations [ Time Frame: within 3 years ]


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Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women using an intrauterine system/device (hormonal IUS or copper IUD)
Criteria

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 surveillance

Exclusion Criteria:

  • Women aged 40 or older at insertion day
  • Women who are currently enrolled in an interventional trial on IUD use can't participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146950


Contacts
Contact: Christine Hagemann, MSc 00493094510143 hagemann@zeg-berlin.de
Contact: Klaas Heinemann, PhD, MD, MSc, MBA 00493094510120 k.heinemann@zeg-berlin.de

Locations
Germany
Center for Epidemiology and Health Research Berlin Recruiting
Berlin, Germany, 10115
Contact: Christine Hagemann, MSc    00493094510143    hagemann@zeg-berlin.de   
Contact: Klaas Heinemann, PhD, MD, MSc, MBA    00493094510120    k.heinemann@zeg-berlin.de   
Principal Investigator: Klaas Heinemann, PhD, MD, MSc, MBA         
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Klaas Heinemann, PhD, MD, MSc, MBA Center for Epidemiology and Health Research Berlin

Responsible Party: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT02146950     History of Changes
Other Study ID Numbers: ZEG2013_10
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Keywords provided by Center for Epidemiology and Health Research, Germany:
LCS-12
Intrauterine Device (IUD)
Intrauterine System (IUS)
Levonorgestrel
Pearl Index
Hormonal Contraception